DEN250043 · Cm Technologies, Inc. · SJB · Aug 20, 2026 · Gastroenterology, Urology
Device Facts
Record ID
DEN250043
Device Name
Qoramatic Automated Stool Management
Applicant
Cm Technologies, Inc.
Product Code
SJB · Gastroenterology, Urology
Decision Date
Aug 20, 2026
Decision
DENG
Submission Type
Direct
Regulation
21 CFR 876.5230
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Qoramatic Automated Stool Management device is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients. Adults use only.
Device Story
Qoramatic Automated Stool Management is a powered fecal management system designed for bedridden adult patients. The device utilizes powered components to divert and contain liquid or semi-liquid fecal waste, preventing skin contact. System includes accessories such as filters, conduits for waste transfer, and receptacles for containment. Operated in clinical settings, the device requires monitoring of powered functions by healthcare providers. By automating waste diversion, the system aims to reduce complications associated with fecal exposure, such as skin irritation or tissue injury. Clinical and non-clinical performance data, including pressure evaluation during insertion/operation/withdrawal, support safety and effectiveness.
Clinical Evidence
Clinical performance data required to demonstrate intended performance under anticipated conditions. Data must include records of powered operation, device failures, and all adverse events, specifically fecal leakage and complications during insertion, operation, or withdrawal.
Technological Characteristics
Powered fecal management system; includes filters, conduits, and receptacles. Requires biocompatibility evaluation of patient-contacting components, electrical safety, electromagnetic compatibility, and mechanical safety testing. Includes software for powered function control. Shelf life testing required for package integrity and functionality.
Indications for Use
Indicated for fecal management in bedridden adult patients to divert and collect liquid or semi-liquid stool and minimize skin contact.
Regulatory Classification
Identification
The Qoramatic Automated Stool Management device is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients. Adults use only. A powered fecal management system is a device that uses powered components to partially or fully divert and contain fecal waste away from a bed-ridden patient. This classification includes accessories such as filters, conduits for fecal waste transfer, and receptacles for fecal waste containment.
Special Controls
In combination with the general controls of the FD&C Act, the powered fecal management system is subject to the following special controls:
(1) Clinical performance data must demonstrate that the device performs as intended under its anticipated conditions of use in all intended use environments. Data must include:
(i) Records of powered device operation over the duration of clinical use;
(ii) Device failures; and
(iii) All adverse events, including fecal leakage and any adverse events during insertion, operation, and withdrawal of the device.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under its anticipated conditions of use and all intended use environments. The testing must include:
(i) Simulated testing of fecal waste diversion and containment with powered functions for the expected duration of use; and
(ii) Evaluation of pressures exerted on and within the rectum during insertion, operation, and withdrawal of the device over the intended duration of use.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance data must demonstrate the electromagnetic compatibility, electrical safety, and mechanical safety of the device.
(6) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.
(7) Labeling must include:
(i) Intended duration of use for the device;
(ii) Information on each powered function, including how operators can monitor and control any powered function; and
(iii) A summary of the clinical data pertinent to use of the device, including device-related complications or adverse events.
Submission Summary (Full Text)
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**U.S. FOOD & DRUG**
ADMINISTRATION
August 20, 2026
Cm Technologies, Inc.
% Alan Donald
President
Matrix Medical Consulting, Inc.
Hyundai Office Bldg.
8880 Rio San Diego Dr., Suite 800
San Diego, California 92108
Re: DEN250043
Trade/Device Name: Qoramatic Automated Stool Management
Regulation Number: 21 CFR 876.5230
Regulation Name: Powered fecal management system
Regulatory Class: Class II
Product Code: SJB
Dated: September 12, 2025
Received: September 15, 2025
Dear Alan Donald:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the Qoramatic Automated Stool Management, a prescription device under 21 CFR Part 801.109 with the following indications for use:
The Qoramatic Automated Stool Management device is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients. Adults use only.
FDA concludes that this device should be classified into Class II. This order, therefore, classifies the Qoramatic Automated Stool Management, and substantially equivalent devices of this generic type, into Class II under the generic name powered fecal management system.
FDA identifies this generic type of device as:
**Powered fecal management system.** A powered fecal management system is a device that uses powered components to partially or fully divert and contain fecal waste away from a bed-ridden patient. This classification includes accessories such as filters, conduits for fecal waste transfer, and receptacles for fecal waste containment.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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DEN250043 - Alan Donald
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Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This law provides two options for De Novo classification. First, any person who receives a "not substantially equivalent" (NSE) determination in response to a 510(k) for a device that has not been previously classified under the Act may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. On December 13, 2016, the 21st Century Cures Act removed a requirement that a De Novo request be submitted within 30 days of receiving an NSE determination. Alternatively, any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k). FDA shall, within 120 days of receiving such a request, classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing the classification.
On September 15, 2025, FDA received your De Novo requesting classification of the Qoramatic Automated Stool Management. The request was submitted under section 513(f)(2) of the FD&C Act. In order to classify the Qoramatic Automated Stool Management into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the De Novo request FDA has determined that, for the previously stated indications for use, the Qoramatic Automated Stool Management can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type. The identified risks and mitigation measures associated with the device type are summarized in the following table:
| Risk to Health | Mitigation Measures |
| --- | --- |
| Tissue injury, irritation, or inflammation due to: - Extended device placement and duration of use - Device failure or malfunction of fecal waste diversion and containment features - Insufficient fecal waste diversion and containment - Device withdrawal/expulsion - Use error | Clinical performance data Non-clinical performance testing Software verification, validation, and hazard analysis Labeling |
| Infection due to insufficient fecal waste diversion and containment | Clinical performance data Non-clinical performance testing Software verification, validation, and hazard analysis Labeling |
| Device malfunction leading to injury to user/patient (e.g., shock, burn, interference) | Non-clinical performance testing Electrical safety testing Software verification, validation, and hazard analysis Electromagnetic compatibility testing Labeling |
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DEN250043 - Alan Donald
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| | Shelf life testing |
| --- | --- |
| Adverse tissue reaction | Biocompatibility evaluation |
In combination with the general controls of the FD&C Act, the powered fecal management system is subject to the following special controls:
(1) Clinical performance data must demonstrate that the device performs as intended under its anticipated conditions of use in all intended use environments. Data must include:
(i) Records of powered device operation over the duration of clinical use;
(ii) Device failures; and
(iii) All adverse events, including fecal leakage and any adverse events during insertion, operation, and withdrawal of the device.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under its anticipated conditions of use and all intended use environments. The testing must include:
(i) Simulated testing of fecal waste diversion and containment with powered functions for the expected duration of use; and
(ii) Evaluation of pressures exerted on and within the rectum during insertion, operation, and withdrawal of the device over the intended duration of use.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance data must demonstrate the electromagnetic compatibility, electrical safety, and mechanical safety of the device.
(6) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.
(7) Labeling must include:
(i) Intended duration of use for the device;
(ii) Information on each powered function, including how operators can monitor and control any powered function; and
(iii) A summary of the clinical data pertinent to use of the device, including device-related complications or adverse events.
In addition, this is a prescription device and must comply with 21 CFR 801.109.
Although this letter refers to your product as a device, please be aware that some granted products may instead be combination products. If you have questions on whether your product is a combination product, contact CDRHProductJurisdiction@fda.hhs.gov.
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device
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DEN250043 - Alan Donald
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type. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, the device is not exempt from the premarket notification requirements of the FD&C Act. Thus, persons who intend to market this device type must submit a premarket notification containing information on the powered fecal management system they intend to market prior to marketing the device.
Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the FD&C Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and if applicable, the electronic product radiation control provisions (Sections 531-542 of the FD&C Act; 21 CFR 1000-1050).
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System Rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection between 9 a.m. and 4 p.m., Monday through Friday.
As a result of this order, you may immediately market your device as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.
For comprehensive regulatory information about medical devices and radiation-emitting products, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
If you have any questions concerning the contents of the letter, please contact Virag Patel at (301) 796-0452.
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Sincerely,
SHANIL P. HAUGEN -S
Shanil P. Haugen, Ph.D.
Acting Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
