510(k) Report

510(k) · Cleared

Cleared

Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet

K192666510(k) TraditionalCleared Dec 2, 201968-day reviewClass II21 CFR 878.4850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Promisemed Hangzhou Meditech Co., Ltd. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Cleared on Dec 2, 2019 as substantially equivalent to K113513 (Micropoint Technologies Pte, Ltd., 2012) and 1 other predicate after a 68-day review. Its family tree reaches back 2 generations to 1982. 45 later devices descend from it.

Decided
Dec 2, 2019
Review
68 days
Class
Class II
Product code
FMK
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K822209 (1982). 4 ancestors in all. 45 later devices descend from it, 12 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor1993: 1 other ancestor2022: 16 descendants cleared2023: 3 descendants cleared2024: 13 descendants cleared2025: 6 descendants cleared2026: 7 descendants clearedK822209 · Autolancet · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1982K101145 · Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 · Medipurpose Pte., Ltd. · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 12 descendants2 generations forward: 22 descendants3 generations forward: 8 descendants4 generations forward: 3 descendants K101145 · Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 · Medipurpose Pte., Ltd. · 2010K822209 · Autolancet · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19820
  1. Root · 2 generations backK822209 AutolancetBd Becton Dickinson Vacutainer Systems Preanalytic · 1982
  2. 1 generation backK101145 Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300…Medipurpose Pte., Ltd. · 2010
  3. This deviceK192666 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2019
  4. Descendant · cites it directly · 14 of its ownK220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd. · 2022
  5. Descendant · cites it directly · 7 of its ownK220475 Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T…Tianjin Huahong Technology Co., Ltd. · 2022
  6. Descendant · cites it directly · 5 of its ownK221507 Disposable Blood LancetSteriLance Medical (Suzhou), Inc. · 2022
  7. Descendant · cites it directly · 4 of its ownK221368 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2022
  8. Descendant · 2 generations on · 3 of its ownK243306 Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII…Tianjin Huahong Technology Co., Ltd. · 2024

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2022: 162023: 32024: 132025: 62026: 7
2022high 16 (2022) · low 3 (2023)2026

Most influential descendants

Showing 5 of 45 · See all
  • K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd. · 2022 · cites it directly14descendants
  • K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T…Tianjin Huahong Technology Co., Ltd. · 2022 · cites it directly7descendants
  • K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc. · 2022 · cites it directly5descendants
  • K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. · 2022 · cites it directly4descendants
  • K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…Tianjin Huahong Technology Co., Ltd. · 2024 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K822209AutolancetBd Becton Dickinson Vacutainer Systems Preanalytic1982—
−1K101145Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250Medipurpose Pte., Ltd.2010—
0 (this device)K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.2019—
+1K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd.2022—
+1K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T…Tianjin Huahong Technology Co., Ltd.2022—
+1K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc.2022—
+1K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.2022—
+2K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)…Tianjin Huahong Technology Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
2022160
202330
2024130
202560
202670
FIG. 1 — Lineage of K192666, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FMK device

  1. #1 K220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII…score 25.0 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K113513Plancet
Summary page 5
…1 Promisemed Blood Lancet & Safety Lancet 510(k) Submission-K192666 4 Identification of Predicate Device(s) K113513 PLANCET blood lancet K101145 SurgiLance® Safety Lancet 5 Description of the Device Promosemed Blood Lancet is a sterile, ha…
Micropoint Technologies Pte, Ltd.2012—
*K101145Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
Summary page 5
…= Page 5 === Promisemed Blood Lancet & Safety Lancet 510(k) Submission-K192666 4 Identification of Predicate Device(s) K113513 PLANCET blood lancet K101145 SurgiLance® Safety Lancet 5 Description of the Device Promosemed Blood Lancet is a sterile, handheld, sharply-pointed, non-…
Medipurpose Pte., Ltd.2010—

What descends from it? (45)

See all 45

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd.202214
K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T…Tianjin Huahong Technology Co., Ltd.20227
K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc.20225
K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.20224
K222090Safety LancetNingbo Medsun Medical Co., Ltd.20222
K221521Disposable Safety LancetSteriLance Medical (Suzhou), Inc.20221
K223314Disposable Blood LancetsHuaian Hening Medical Instruments Co., Ltd.20230
K222055Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd.20220
K221383MedtFine Blood LancetShanghai Carelife International Trading Co., Ltd.20220
K221839LancetHebei Xinle Sci&Tech Co., Ltd.20220

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 28.2 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K220370 (Tianjin Huahong Technology Co., Ltd., 2022) has gone furthest, with 14 descendants of its own.

How does its category compare?

All FMK devices

FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · FMK

4in 2025

2010: 22012: 22013: 12016: 12017: 12019: 22021: 12022: 252023: 102024: 102025: 42026 (partial year): 5
2007high 25 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMK

59in 2025

2022: 87 days median2023: 95 days median2024: 57 days median2025: 59 days median2026 (partial year): 68 days median
2007high 95 (2023) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMK

1in 2009

2007: 42008: 22009: 1
2007high 4 (2007) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FMK

47in 2025

2007: 1,2062008: 1,1002009: 8822010: 9102011: 1,4932012: 1,5732013: 1,3012014: 8902015: 7812016: 5392017: 5312018: 5342019: 3992020: 3132021: 2452022: 2542023: 2822024: 2432025: 47
2007high 1,573 (2012) · low 47 (2025)2025

MAUDE reports naming product code FMK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—41,206
20080—21,100
20090—1882
20102—0910
20110—01,493
20122—01,573
20131—01,301
20140—0890
20150—0781
20161—0539
20171—0531
20180—0534
20192—0399
20200—0313
20211—0245
202225870254
202310950282
202410570243
2025459047
20265680—

What is it indicated for?

It is intended for capillary blood sampling.

Indications for use as stated in the FDA summary.

More from Promisemed Hangzhou Meditech Co., Ltd.

36 FDA decisions under this applicant name. See the company

  • K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2026
  • K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
  • K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd. · 2026
  • K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd. · 2026
  • K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd. · 2025

Recent decisions in FMK

The FMK category page

  • K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd. · 2026
  • K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd. · 2026
  • K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd. · 2026
  • K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd. · 2026
  • K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd. · 2026

https://510kreport.com/device/K192666 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192666: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192666

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026