DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
K072641 · Famidoc Technology Co., Ltd. · FLL · Nov 1, 2007 · General Hospital
Device Facts
Record ID
K072641
Device Name
DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
Applicant
Famidoc Technology Co., Ltd.
Product Code
FLL · General Hospital
Decision Date
Nov 1, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.2910
Device Class
Class 2
Attributes
Pediatric, 3rd-Party Reviewed
Indications for Use
Famidoc Digital Clinical Thermometer Model FDTH-V0-1、FDTH-V0-2、 FDTH-V0-3、 FDTH-V0-4 are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.
Device Story
Hand-held, battery-operated digital thermometer; measures human body temperature via thermistor sensor. Input: thermal signal from axillary, oral, or rectal contact. Operation: thermistor resistance compared against reference resistor; ASIC processes signal; LCD displays temperature; buzzer provides audible feedback. Used by clinicians or patients in hospital or home. Output: digital temperature reading. Benefits: provides accurate, repeatable temperature monitoring for clinical or personal health management.
Clinical Evidence
Clinical tests performed to verify repeatability and standard deviation in accordance with EN 12470-3:2000. Bench testing confirmed accuracy, precision, and repeatability per ASTM E1112-00, IEC 60601-1, and IEC 60601-1-2.
Technological Characteristics
Hand-held electronic thermometer; thermistor-based sensing; ASIC-based signal processing; battery-powered; LCD display; buzzer. Complies with ASTM E1112-00, IEC 60601-1, IEC 60601-1-2, and EN 12470-3:2000. Materials identical to legally marketed devices.
Indications for Use
Indicated for measurement and monitoring of human body temperature in all ages, including infants, children, and adults, for use by clinicians or consumers in hospital or home settings. No contraindications specified.
Regulatory Classification
Identification
A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
Special Controls
(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
Predicate Devices
Actherm digital clinical thermometer Model: ACT 2000 (K010238)
Submission Summary (Full Text)
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## Chapter 13 510(K) Summary
# 510(K) SUMMARY
NOV - 1 2007
Famidoc Digital Clinical Thermometer FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR § 807.92
| 1.0 Submitter's Name: | FAMIDOC TECHNOLOGY CO., LTD. |
|-----------------------|--------------------------------------------------------------------------------------------------|
| Address: | 6/F,G Building ,No.14, Liuxian 1st RD.71 Block<br>Baoan District, Shenzhen,Guangdong,P.R. China. |
| Phone: | 86-755-27864337 Ext.807 |
| Fax: | 86-755-27864151 |
| Contact: | Mr. Steeljin, |
| E-mail: | steeljin@famidoc.com<br>leon@famidoc.com |
| Date | October 11, 2007 |
| 2.0 Device Name: | Famidoc digital clinical thermometer |
|----------------------|--------------------------------------------|
| Model: | FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4 |
| Classification Name: | Clinical Electronic Thermometer |
### 3.0 Classification: Class II
### 4.0 Predicate Device Information:
Actherm digital clinical thermometer Model: ACT 2000. It's 510(K) number is K010238
#### 5.0 Device Description:
Famidoc Digital Clinical Thermometer (model FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4) are hand-held, reusable, battery operated, maximum device that can measures human body temperature.
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Models FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4 have the same indication for use. the difference points are their shapes、waterproof function and measurement speed.
The operation principle is based on thermistor and ASIC technology, a thermistor using as temperature sensor, the sensor's signal is then calculated and displayed by an ASIC. The digital thermometer comprises a thermistor for temperature sensing, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC and a LCD for calculating and displaying the target temperature digitally which the thermistor is immersed.
### 6.0 Intended Use:
Famidoc Digital Clinical Thermometer Model FDTH-V0-1、FDTH-V0-2、 FDTH-V0-3、 FDTH-V0-4 are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.
#### 7.0 Measurement Type:
There are three measurement types to use our thermometer. Axillary measurement, Oral measurement and rectal measurement, when used under the Axillary, it directly contacts body skin. For oral or rectum use, it directly contacts membrane tissue.
#### 8.0 Performance Data:
The devices meet the ASTM Standard Specification for Electronic Thermometer for intermittent Determination of Patient Temperature ( ASTM Ell12-00 ), as well as IEC 60601-1 and IEC 60601-1-2 requirements, Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling. For all body contacting materials, analysis is made that the identical materials have been used in other legally marketed devices under the same use conditions (see Chapter 8 Safety and Effectiveness Evaluation and Risk Analysis, Chapter 10 Biological Compatibility Report). And we had made clinical tests to prove its repeatability and standard deviation are accord with the demand of EN 12470-3:2000 when applied human.
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K072641 (P.3043)
### 9.0 Comparison to Predicate Devices and conclusions
Our Digital Clinical Thermometer Model FDTH-V0-1、FDTH-V0-2、 FDTH-V0-3、 FDTH-V0-4 are substantially equivalent to Actherm digital clinical thermometer Model: ACT 2000, It's 510(k) number is K010238.
They are very similar in design principle, intended use, functions, material and the adopting applicable standards.
Only their outlook and some parameter such as measurement speed, battery life is different. Moreover, tests in this submission provide demonstrate these small difference do not raise and new questions of safety or effectiveness.
Conclusions: the Famidoc Digital Clinical Thermometer Model FDTH-V0-1、FDTH-V0-2、FDTH-V0-3、 FDTH-V0-4 are substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 2007
Famidoc Technology Company, Limited C/O Mr. Tomas Huang Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
Re: K072641
Trade/Device Name: Famidoc Digital Clinical Thermometer FDTH-VO-1, FDTH-VO-2, FDTH-VO-3, FDTH-VO-4 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 17, 2007 Received: October 18, 2007
Dear Mr. Huang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Hang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chis Lins Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known):
Device Name: Famidoc Digital Clinical Thermometer
Indications for Use:
Famidoc Digital Clinical Thermometers are intended for the measurement and monitoring of human body temperature, by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use イ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am
on of Anesthesiology, General Horolhal, Incollion Control, Dental Devices
umber: K912641
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.
