510(k) Report

510(k) · Cleared

Cleared

Autopen

K895890510(k) TraditionalCleared Feb 16, 1990134-day reviewClass II21 CFR 880.5860

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

Ulster Scientific, Inc. · FMF Syringe, Piston

Cleared on Feb 16, 1990 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Feb 16, 1990
Review
134 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2007: 1 descendant cleared1999: 1 descendant cleared2010: 1 descendant cleared2015: 2 descendants cleared2016: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK895890 AutopenUlster Scientific, Inc. · 1990
  2. Descendant · cites it directly · 7 of its ownK983974 Owen Mumford 3ML AutopenOwen Mumford USA, Inc. · 1998 · Recalled
  3. Descendant · 2 generations on · 5 of its ownK063151 Humapen Luxura HDEli Lilly and Co. · 2007
  4. Descendant · 3 generations on · 4 of its ownK100988 Humapen Luxura HDEli Lilly and Company · 2010
  5. Descendant · 4 generations on · 3 of its ownK142518 HumaPen LuxuraEli Lilly and Company · 2015
  6. Descendant · 5 generations on · 1 of its ownK160668 HumaPen SavvioEli Lilly and Company, Inc. · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12007: 12010: 12015: 22016: 12025: 1
1998high 2 (2015) · low 0 (2000)2026

Most influential descendants

Showing 5 of 8 · See all
  • K983974Owen Mumford 3ML AutopenOwen Mumford USA, Inc. · 1998 · cites it directly7descendants
  • K063151Humapen Luxura HDEli Lilly and Co. · 2007 · 2 generations on5descendants
  • K100988Humapen Luxura HDEli Lilly and Company · 2010 · 3 generations on4descendants
  • K142518HumaPen LuxuraEli Lilly and Company · 2015 · 4 generations on3descendants
  • K160668HumaPen SavvioEli Lilly and Company, Inc. · 2016 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895890AutopenUlster Scientific, Inc.1990—
+1K983974Owen Mumford 3ML AutopenOwen Mumford USA, Inc.19981
+2K063151Humapen Luxura HDEli Lilly and Co.2007—
+3K100988Humapen Luxura HDEli Lilly and Company2010—
+4K142518HumaPen LuxuraEli Lilly and Company2015—
+5K160668HumaPen SavvioEli Lilly and Company, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200710
201010
201520
201610
202510
FIG. 1 — Lineage of K895890, 1990–2025Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMF? 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 FMF device

  1. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K983974Owen Mumford 3ML AutopenOwen Mumford USA, Inc.19987

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, K983974 (Owen Mumford USA, Inc., 1998) has gone furthest, with 7 descendants of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

More from Ulster Scientific, Inc.

20 FDA decisions under this applicant name. See the company

  • K942620Feather-Touch Single-Stick DeviceUlster Scientific, Inc. · 1994
  • K920562UnistikUlster Scientific, Inc. · 1992
  • K902592Epc Electronic Pipetting SystemUlster Scientific, Inc. · 1990
  • K894474The Autolet LiteUlster Scientific, Inc. · 1989
  • K885340Air Displacement PipetteUlster Scientific, Inc. · 1989

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K895890 · printed Nov 4, 2026

Cite this page

510(k) Report. “K895890: Autopen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895890

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026