510(k) Report

510(k) · Cleared

Cleared

Cleanlet, Cleanlet XL & Kids

K931827510(k) TraditionalCleared Sep 13, 1993158-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

Gainor Medical Europe, Ltd. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Cleared on Sep 13, 1993 after a 158-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 47 later devices descend from it.

Decided
Sep 13, 1993
Review
158 days
Class
Class II
Product code
FMK
Recalls
None
Predicates
0

47 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2019: 1 descendant cleared2022: 16 descendants cleared2023: 3 descendants cleared2024: 13 descendants cleared2025: 6 descendants cleared2026: 7 descendants cleared1990200020102020
  1. This deviceK931827 Cleanlet, Cleanlet XL & KidsGainor Medical Europe, Ltd. · 1993
  2. Descendant · cites it directly · 46 of its ownK113513 PlancetMicropoint Technologies Pte, Ltd. · 2012
  3. Descendant · 2 generations on · 45 of its ownK192666 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2019
  4. Descendant · 3 generations on · 14 of its ownK220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd. · 2022
  5. Descendant · 3 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 · 3 generations on · 5 of its ownK221507 Disposable Blood LancetSteriLance Medical (Suzhou), Inc. · 2022

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2012: 12019: 12022: 162023: 32024: 132025: 62026: 7
2012high 16 (2022) · low 0 (2013)2026

Most influential descendants

Showing 5 of 47 · See all
  • K113513PlancetMicropoint Technologies Pte, Ltd. · 2012 · cites it directly46descendants
  • K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. · 2019 · 2 generations on45descendants
  • K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd. · 2022 · 3 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 · 3 generations on7descendants
  • K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc. · 2022 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931827Cleanlet, Cleanlet XL & KidsGainor Medical Europe, Ltd.1993—
+1K113513PlancetMicropoint Technologies Pte, Ltd.2012—
+2K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.2019—
+3K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd.2022—
+3K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T…Tianjin Huahong Technology Co., Ltd.2022—
+3K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201910
2022160
202330
2024130
202560
202670
FIG. 1 — Lineage of K931827, 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (47)

See all 47

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

NumberDeviceApplicantDecidedDescendants
K113513PlancetMicropoint Technologies Pte, Ltd.201246

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?

  • Of its descendants, K113513 (Micropoint Technologies Pte, Ltd., 2012) has gone furthest, with 46 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.

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—

More from Gainor Medical Europe, Ltd.

13 FDA decisions under this applicant name. See the company

  • K926448I.V. Administration SetGainor Medical Europe, Ltd. · 1994
  • K931828Carelet Safety LancetGainor Medical Europe, Ltd. · 1993
  • K922441Sureseal BandageGainor Medical Europe, Ltd. · 1993
  • K913333I.V. Priming SetGainor Medical Europe, Ltd. · 1991
  • K902422Needle, Aspiration & Injection, DisposableGainor Medical Europe, Ltd. · 1991

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/K931827 · printed Nov 4, 2026

Cite this page

510(k) Report. “K931827: Cleanlet, Cleanlet XL & Kids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931827

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026