510(k) Report

510(k) · Cleared

Cleared

Plancet

K113513510(k) TraditionalCleared Jul 13, 2012228-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

Micropoint Technologies Pte, Ltd. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Cleared on Jul 13, 2012 as substantially equivalent to K931827 (Gainor Medical Europe, Ltd., 1993) after a 228-day review. Its family tree reaches back 1 generation to 1993. 46 later devices descend from it.

Decided
Jul 13, 2012
Review
228 days
Class
Class II
Product code
FMK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K931827 (1993). 46 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2022: 16 descendants cleared2023: 3 descendants cleared2024: 13 descendants cleared2025: 6 descendants cleared2026: 7 descendants clearedK931827 · Cleanlet, Cleanlet XL & Kids · Gainor Medical Europe, Ltd. · 19931990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 12 descendants3 generations forward: 22 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants K931827 · Cleanlet, Cleanlet XL & Kids · Gainor Medical Europe, Ltd. · 19930+5
  1. Root · 1 generation backK931827 Cleanlet, Cleanlet XL & KidsGainor Medical Europe, Ltd. · 1993
  2. This deviceK113513 PlancetMicropoint Technologies Pte, Ltd. · 2012
  3. Descendant · cites it directly · 45 of its ownK192666 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2019
  4. Descendant · 2 generations on · 14 of its ownK220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd. · 2022
  5. Descendant · 2 generations on · 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 · 2 generations on · 5 of its ownK221507 Disposable Blood LancetSteriLance Medical (Suzhou), Inc. · 2022
  7. Descendant · 2 generations on · 4 of its ownK221368 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2022

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2019: 12022: 162023: 32024: 132025: 62026: 7
2019high 16 (2022) · low 0 (2020)2026

Most influential descendants

Showing 5 of 46 · See all
  • K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. · 2019 · cites it directly45descendants
  • K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd. · 2022 · 2 generations on14descendants
  • 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 · 2 generations on7descendants
  • K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc. · 2022 · 2 generations on5descendants
  • K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. · 2022 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931827Cleanlet, Cleanlet XL & KidsGainor Medical Europe, Ltd.1993—
0 (this device)K113513PlancetMicropoint Technologies Pte, Ltd.2012—
+1K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.2019—
+2K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd.2022—
+2K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T…Tianjin Huahong Technology Co., Ltd.2022—
+2K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc.2022—
+2K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
2022160
202330
2024130
202560
202670
FIG. 1 — Lineage of K113513, 1993–2026Source: 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
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What was it cleared against? (1)

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
*K931827Cleanlet, Cleanlet XL & Kids
Summary page 1
…s I (Exempt) Classification Name: Lancet, Blood (Product Code: FMK, Regulation No. 878.4800) Legally Marketed CLEANLET, CLEANLET XL & KIDS (K93 1827) Predicate Device Description of the The PLANCET blood lancet is a needle device to be loaded in a…
Gainor Medical Europe, Ltd.1993—

What descends from it? (46)

See all 46

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.201945

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?

  • Its one ancestor has no recall.
  • Of its descendants, K192666 (Promisemed Hangzhou Meditech Co., Ltd., 2019) has gone furthest, with 45 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. 2012, 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?

The PLANCET blood lancet is a puncture device to obtain micro-litre capillary whole blood samples from finger tips or palm or alternate body sites. The PLANCET blood lancet is normally loaded in a spring-operated lancing device for rapid puncture of skin.

Indications for use as stated in the FDA summary.

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/K113513 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113513: Plancet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113513

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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