510(k) Report

510(k) · Cleared

Cleared

Devon Standard Syringe, Hypodermic Needle and Insulin Syringe

K052551510(k) TraditionalCleared Sep 30, 200514-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

Devon Safety Products, Inc. · FMF Syringe, Piston

Cleared on Sep 30, 2005 as substantially equivalent to K980181 (Terumo Medical Corp., 1998) and 3 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1977.

Decided
Sep 30, 2005
Review
14 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K771205 (1977). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1994: 2 other ancestorsK771205 · Hypodermic Syringe · Terumo America, Inc. · 1977K980181 · Terumo Disposable Hypodermc Syringe · Terumo Medical Corp. · 1998 · recalledK021993 · Shanchuan Syringe · Shangdong Zibo Shanchuan Medical Instruments Co. · 20031975198019851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K021993 · Shanchuan Syringe · Shangdong Zibo Shanchuan Medical Instruments Co. · 2003K980181 · Terumo Disposable Hypodermc Syringe · Terumo Medical Corp. · 1998 · recalledK771205 · Hypodermic Syringe · Terumo America, Inc. · 19770
  1. Root · 3 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
  2. 2 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
  3. 1 generation backK021993 Shanchuan SyringeShangdong Zibo Shanchuan Medical Instruments Co. · 2003
  4. This deviceK052551 Devon Standard Syringe, Hypodermic Needle and Insulin SyringeDevon Safety Products, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K771205Hypodermic SyringeTerumo America, Inc.1977—
−2K980181Terumo Disposable Hypodermc SyringeTerumo Medical Corp.19981
−1K021993Shanchuan SyringeShangdong Zibo Shanchuan Medical Instruments Co.2003—
0 (this device)K052551Devon Standard Syringe, Hypodermic Needle and Insulin SyringeDevon Safety Products, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
200110
FIG. 1 — Lineage of K052551, 1977–2005Source: 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 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 16.1 · 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? (4)

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
*K980181Terumo Disposable Hypodermc Syringe
Summary page 1
…ious trade names COMMON NAME: Piston Syringe and Hypodermic Needle SUBSTANTIALLY EQUIVALENT TO: The Devon Standard Syringe is substantially equivalent to: 1K980181: Terumo, Disposable Hypodermic Syringe K(941657: Becton Dickinson, Insulin Syringes. K(021993: Shandong Zibo Shanchuan Medical In…
Terumo Medical Corp.19981
*K941657BD Micro Fine, Ultra Fine, and Allergy Syringe
Summary page 1
…Syringe and Hypodermic Needle SUBSTANTIALLY EQUIVALENT TO: The Devon Standard Syringe is substantially equivalent to: 1K980181: Terumo, Disposable Hypodermic Syringe K(941657: Becton Dickinson, Insulin Syringes. K(021993: Shandong Zibo Shanchuan Medical Instrument, Co., Ltd., Piston Syringe, Hypodermic…
Bd Becton Dickinson Vacutainer Systems Preanalytic1994—
*K021993Shanchuan Syringe
Summary page 1
…QUIVALENT TO: The Devon Standard Syringe is substantially equivalent to: 1K980181: Terumo, Disposable Hypodermic Syringe K(941657: Becton Dickinson, Insulin Syringes. K(021993: Shandong Zibo Shanchuan Medical Instrument, Co., Ltd., Piston Syringe, Hypodermic Needle: Insulin Syringe K(013293: Nipro Medica…
Shangdong Zibo Shanchuan Medical Instruments Co.2003—
*K013293Nipro Hypodermic Needle
Summary page 1
…ringe K(941657: Becton Dickinson, Insulin Syringes. K(021993: Shandong Zibo Shanchuan Medical Instrument, Co., Ltd., Piston Syringe, Hypodermic Needle: Insulin Syringe K(013293: Nipro Medical Corp., Hypodermic Needle. DESCRIPTION of the DEVICE: The Devon Standard Syringe is a sterile, single use, disposa…
Nipro Medical Corp.2001—

Also cleared against K980181: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 28 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 5 other devices also cite its predicate K980181.

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)—

What is it indicated for?

This device is intended for injection of fluids into, or withdrawing fluids from, parts of the body below the surface of the skin.

Syringe with plunger for general medical uses.

The Insulin syringes are intended for insulin injection.

Indications for use as stated in the FDA summary.

Also cleared against K980181

5 other devices cite the same predicate.

  • K053413Terumo Syringe for Administration of UV Sensitive MedicinesTerumo Europe N.V. · 2006
  • K031453Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
  • K021993Shanchuan SyringeShangdong Zibo Shanchuan Medical Instruments Co. · 2003
  • K023271Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
  • K022495Gettig Disposable SyringesGettig Pharmaceutical Instrument Co. · 2002

More from Devon Safety Products, Inc.

2 FDA decisions under this applicant name. See the company

  • K060668Safe Tip SyringeDevon Safety Products, Inc. · 2006

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/K052551 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052551: Devon Standard Syringe, Hypodermic Needle and Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052551

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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