510(k) Report

510(k) · Cleared

Cleared

ON Call Chosen Lancing Device

K113332510(k) AbbreviatedCleared Apr 18, 2012156-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

ACON Laboratories, Inc. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Cleared on Apr 18, 2012 as substantially equivalent to K090057 (Acon Laboratories Co., 2009) after a 156-day review. Its family tree reaches back 2 generations to 2000. 16 later devices descend from it.

Decided
Apr 18, 2012
Review
156 days
Class
Class II
Product code
FMK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K002134 (2000). 16 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2022: 5 descendants cleared2016: 1 descendant cleared2023: 2 descendants cleared2024: 3 descendants cleared2025: 2 descendants cleared2026: 3 descendants clearedReference device: K111371 · ON Call Chosen Blood Glucose Monitoring System · ACON Laboratories, Inc. · 2011K002134 · One Touch Ultra Blood Glucose Monitoring System · Selfcare, Inc. · 2000K090057 · ON-Call Plus Blood Glucose Monitoring System · Acon Laboratories Co. · 2009200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 3 descendants K090057 · ON-Call Plus Blood Glucose Monitoring System · Acon Laboratories Co. · 2009K002134 · One Touch Ultra Blood Glucose Monitoring System · Selfcare, Inc. · 20000
  1. Root · 2 generations backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
  2. 1 generation backK090057 ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009
  3. This deviceK113332 ON Call Chosen Lancing DeviceACON Laboratories, Inc. · 2012
  4. 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
  5. 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
  6. Descendant · cites it directly · 3 of its ownK153670 Genteel Lancing DeviceGenteel, LLC · 2016
  7. Descendant · cites it directly · 2 of its ownK221970 Lancing deviceSteriLance Medical (Suzhou), Inc. · 2022
  8. Descendant · cites it directly · 1 of its ownK221062 RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing…Bionime Corporation · 2022

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2016: 12022: 52023: 22024: 32025: 22026: 3
2016high 5 (2022) · low 0 (2017)2026

Most influential descendants

Showing 5 of 16 · See all
  • 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
  • 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
  • K153670Genteel Lancing DeviceGenteel, LLC · 2016 · cites it directly3descendants
  • K221970Lancing deviceSteriLance Medical (Suzhou), Inc. · 2022 · cites it directly2descendants
  • K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation · 2022 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002134One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc.2000—
−1K090057ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co.2009—
0 (this device)K113332ON Call Chosen Lancing DeviceACON Laboratories, Inc.2012—
+1K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T…Tianjin Huahong Technology 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—
+1K153670Genteel Lancing DeviceGenteel, LLC2016—
+1K221970Lancing deviceSteriLance Medical (Suzhou), Inc.2022—
+1K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202250
202320
202430
202520
202630
FIG. 1 — Lineage of K113332, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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
*K090057ON-Call Plus Blood Glucose Monitoring System
Summary page 1
…On Call® Plus Lancing Device under On Call® Plus Blood Glucose Monitoring System. ACON Laboratories Inc., 10125 Mesa Rim Road, San Diego, CA 92121, USA 5 10(k) Number: K09005 7 Device Name: V On Call Lancing Device _____________ Proprietary Name Classification Product…
Acon Laboratories Co.2009—
†K111371ON Call Chosen Blood Glucose Monitoring SystemACON Laboratories, Inc.2011—

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
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
K153670Genteel Lancing DeviceGenteel, LLC20163
K221970Lancing deviceSteriLance Medical (Suzhou), Inc.20222
K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation20221
K222656LDE4 Lancing DeviceI-Sens, Inc.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 12 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K220475 (Tianjin Huahong Technology Co., Ltd., 2022) has gone furthest, with 7 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 On Call® Lancing Device is used with On Call® disposable sterile lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for blood glucose testing or other testing utilizing small amounts of blood. The On Call® Lancing Device is intended to be used by a single patient and should not be shared.

Indications for use as stated in the FDA summary.

More from ACON Laboratories, Inc.

86 FDA decisions under this applicant name. See the company

  • K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc. · 2026
  • K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc. · 2025
  • K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc. · 2025
  • K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone…ACON Laboratories, Inc. · 2025
  • K250377Flowflex Plus COVID-19 + Flu A/B Home TestACON Laboratories, Inc. · 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/K113332 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113332: ON Call Chosen Lancing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113332

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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