K261634 · SteriLance Medical (Suzhou), Inc. · QRK · Jun 12, 2026 · General, Plastic Surgery
Device Facts
Record ID
K261634
Device Name
Disposable Blood Lancet (Soft)
Applicant
SteriLance Medical (Suzhou), Inc.
Product Code
QRK · General, Plastic Surgery
Decision Date
Jun 12, 2026
Decision
SESE
Submission Type
Special
Regulation
21 CFR 878.4850
Device Class
Class 2
Attributes
Pediatric
Indications for Use
Disposable Blood Lancet is used for capillary blood collection.
Device Story
Disposable Blood Lancet is a single-use, sterile device for capillary blood collection. It consists of a stainless steel needle encapsulated in a polyethylene body with a protective cap. The user twists off the cap to expose the needle tip for manual skin puncture. The device is intended for over-the-counter use by adults and pediatric patients. It is sterilized via gamma irradiation to a 10^-6 sterility assurance level. The device functions as a passive, manual tool; it does not involve electronic components, software, or automated processing. It provides a simple, disposable mechanism for obtaining small blood samples for diagnostic testing.
Clinical Evidence
Bench testing only. No clinical data was required or provided. Performance testing included product appearance, needle cap position, dimensions, needle diameter, exposed length, bonding firmness, tip sharpness, cleanliness, and biological safety. Biocompatibility testing followed ISO 10993-1, including cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity. All tests met acceptance criteria.
Technological Characteristics
Materials: Stainless steel needle, polyethylene needle body and cap. Dimensions: Available in 21G, 23G, 25G, 26G, 28G, 30G, 31G, 32G, 33G. Sterilization: Gamma irradiation (SAL 10^-6). Design: Manual, single-use, non-powered, passive device. Biocompatibility: Compliant with ISO 10993 series.
Indications for Use
Indicated for capillary blood collection in adult and pediatric populations.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
*Single use only blood lancet without an integral sharps injury prevention feature* —(1)*Identification.* A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
*Multiple use blood lancet for single patient use only* —(1)*Identification.* A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
*Multiple use blood lancet for multiple patient use* —(1)*Identification.* A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class III (premarket approval).(3)
*Date PMA or notice of completion of a PDP is required:* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
{0}
**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 12, 2026
SteriLance Medical (Suzhou), Inc.
Susan Sun
Primary Correspondent
#168 Putuoshan Rd.
New District
Suzhou, Jiangsu 215153
China
RE: K261634
Trade/Device Name: Disposable Blood Lancet (Soft)
Regulation Number: 21 CFR 878.4850
Regulation Name: Blood lancets
Regulatory Class: Class II
Product Code: QRK
Dated: May 17, 2026
Received: May 18, 2026
Dear Susan Sun:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K261634 - Susan Sun
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, 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-
{2}
K261634 - Susan Sun
Page 3
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).
Sincerely,
Colin K.
Chen -S
Digitally signed by
Colin K. Chen -S
Date: 2026.06.12
08:02:58 -04'00'
Colin Kejing Chen, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K261634
Device Name
Disposable Blood Lancet
Indications for Use (Describe)
Disposable Blood Lancet is used for capillary blood collection.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
{4}
# 510(K) Summary – K261634
Prepared in accordance with the requirements of 21 CFR Part 807.92
**Prepared Date: June 11, 2026**
## 1. Submitter
Name: SteriLance Medical (Suzhou) Inc.
Address: No.168 PuTuoShan Road, New District, 215153 Suzhou, Jiangsu, P. R. China
Contact person: Susan Sun
Title: Regulatory Affairs Manager
E-mail: registration@sterilance.com
Tel: 86-0512-65799308 Ext 8301
## 2. Subject Device Information
| Trade/Device Name | Disposable Blood Lancet |
| --- | --- |
| Model | Soft |
| Common Name | Blood Lancet |
| Regulatory Class | Class II |
| Classification Name | Single Use Only Blood Lancet without an Integral Sharps Injury Prevention Feature |
| Product Code | QRK |
| Regulation Number | 21 CFR 878.4850 |
## 3. Predicate Device
SteriLance Medical (Suzhou) Inc., Disposable Blood Lancet, under K221507.
## 4. Device Description
Disposable Blood Lancet is a single-use, sterile medical device designed for capillary blood collection. The device comprises a stainless needle encapsulated within a plastic needle body and protective cap, both of which are made of polyethylene. Prior to use, the protective cap is twisted off to expose the needle tip. The device is sterilized by gamma irradiation, achieving a sterility assurance level (SAL) of $10^{-6}$. The needle body, which encapsulates the stainless steel needle through an injection molding process, forms the sterile barrier system that maintains needle sterility up to the point of use.
## 5. Indication for Use
Disposable Blood Lancet is used for capillary blood collection.
## 6. Technological Characteristics Comparison
Page 1 of 3
{5}
| Comparison item | Subject Device: Disposable Blood Lancet | Predicate Device: Disposable Blood Lancet (K221507) | Comments |
| --- | --- | --- | --- |
| Product Code | QRK | QRK | No change. |
| Manufacturer | SteriLance Medical (Suzhou) Inc. | SteriLance Medical (Suzhou) Inc. | No change. |
| Regulation Number | 21 CFR § 878.4850 | 21 CFR § 878.4850 | No change |
| Classification | Class II | Class II | No change |
| Type of use | OTC | OTC | No change |
| Intended use & Indications for Use | Disposable Blood Lancet is used for capillary blood collection. | Disposable Blood Lancet is used for capillary blood collection. | No change |
| Applicable user | Adult and pediatric | Adult and pediatric | No change |
| Reuse durability | Single use | Single use | No change |
| Sterilization method and SAL | Sterilized by gamma irradiation SAL=10^{-6} | Sterilized by gamma irradiation SAL=10^{-6} | No change |
| Shelf life | 5 Years | 5 Years | No change |
| Component | Needle, needle body, and protective cap | Needle, needle body, and protective cap | No change |
| Specification (needle diameter) | 21G, 23G, 25G, 26G, 28G, 30G, 31G, 32G, 33G | 21G, 23G, 26G, 28G, 30G, 32G, 33G | Difference^{1} |
| Materials | Needle: stainless steel Needle body and cap: Polyethylene | Needle: stainless steel Needle body and cap: Polyethylene | No change |
| Biocompatibility | Complied with ISO 10993 series standards | Complied with ISO 10993 series standards | No change |
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | No change |
Difference$^{1}$: The difference in needle gauge specifications between the subject and predicate devices, specifically, the addition of 25G and 31G, does not raise new questions of safety or effectiveness. Both gauge sizes fall within the range of commercially available lancet specifications, and the addition of these gauges does not alter the device's intended use, design, operating principle, sterilization method, or sterile barrier system.
### Summary of Non-clinical Testing
All non-clinical testing conducted on the subject device was designed to demonstrate that the Disposable Blood Lancet is substantially equivalent to the predicate device (Disposable Blood Lancet, K221507) with respect to critical performance characteristics. Test setup and execution were conducted in accordance with applicable standards. The following performance data were generated to support the substantial equivalence determination.
Page 2 of 3
{6}
# **Performance Testing**
Bench testing was conducted on the subject device to demonstrate that its critical performance characteristics are substantially equivalent to those of the predicate device. All test results have met the applicable acceptable criteria.
- Product appearance and configuration
- Needle cap position
- Basic dimensions
- Steel needle diameter
- Exposed needle length
- Bonding firmness test
- Needle tip sharpness
- Double needle, inverted needle, and empty needle
- Cleanliness
- Biological safety
# **Biocompatibility**
The biocompatibility of the subject device was evaluated in accordance with FDA's guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". All tests passed, and the results are considered applicable to the subject device:
- Cytotoxicity
- Skin sensitization
- Intracutaneous reactivity
- Acute systemic toxicity
- Material-mediated pyrogenicity
# **7. Conclusions**
Based on the totality of the evidence in this submission, including the comparison of Indications for Use, the comparison of technological characteristics, and the performance testing results, the subject device is substantially equivalent to the predicate device. The non-clinical testing demonstrates that the subject device performs as safely and effectively as the predicate device with all evaluated performance characteristics and biocompatibility endpoints. The addition of 25G and 31G needle gauges does not introduce new questions of safety or effectiveness relative to the predicate device.
Page 3 of 3
