510(k) Report

510(k) · Cleared

Cleared

Nipro Disposable Syringes

K030683510(k) TraditionalCleared Oct 31, 2003240-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

Nipro Medical Corp. · FMF Syringe, Piston

Cleared on Oct 31, 2003 as substantially equivalent to K944355 (Nissho Corp., 1994) after a 240-day review. Its family tree reaches back 1 generation to 1994. 23 later devices descend from it.

Decided
Oct 31, 2003
Review
240 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K944355 (1994). 23 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared2005: 1 descendant cleared2006: 4 descendants cleared2008: 2 descendants cleared2010: 1 descendant cleared2024: 4 descendants cleared2012: 1 descendant cleared2020: 1 descendant cleared2021: 3 descendants cleared2026: 3 descendants clearedK944355 · Nipro Branded Disposable Syringes, Needles · Nissho Corp. · 19941990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants K944355 · Nipro Branded Disposable Syringes, Needles · Nissho Corp. · 19940+5
  1. Root · 1 generation backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
  2. This deviceK030683 Nipro Disposable SyringesNipro Medical Corp. · 2003
  3. Descendant · cites it directly · 10 of its ownK051574 Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
  4. Descendant · cites it directly · 9 of its ownK061194 Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210…Smiths Medical Asd, Inc. · 2006
  5. Descendant · 2 generations on · 8 of its ownK063280 Injekt SyringeB.Braun Medical, Inc. · 2006 · Recalled
  6. Descendant · 2 generations on · 7 of its ownK071785 Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge…Smiths Medical Asd, Inc. · 2007
  7. Descendant · 3 generations on · 5 of its ownK211634 Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. · 2021

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2005: 12006: 42007: 32008: 22010: 12012: 12020: 12021: 32024: 42026: 3
2005high 4 (2006) · low 0 (2009)2026

Most influential descendants

Showing 5 of 23 · See all
  • K051574Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005 · cites it directly10descendants
  • K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558Smiths Medical Asd, Inc. · 2006 · cites it directly9descendants
  • K063280Injekt SyringeB.Braun Medical, Inc. · 2006 · 2 generations on8descendants
  • K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Smiths Medical Asd, Inc. · 2007 · 2 generations on7descendants
  • K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. · 2021 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944355Nipro Branded Disposable Syringes, NeedlesNissho Corp.1994—
0 (this device)K030683Nipro Disposable SyringesNipro Medical Corp.2003—
+1K051574Nipro Disposable Syringe with or Without NeedleNipro Medical Corp.2005—
+1K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510…Smiths Medical Asd, Inc.2006—
+2K063280Injekt SyringeB.Braun Medical, Inc.20062
+2K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety…Smiths Medical Asd, Inc.2007—
+3K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200640
200730
200820
201010
201210
202010
202130
202440
202630
FIG. 1 — Lineage of K030683, 1994–2026Source: 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 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? (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
*K944355Nipro Branded Disposable Syringes, Needles
Summary page 1
…Single Lumen Syringe ($880.5860) S8O7.92 (a)(3) Legally Marketed Substantially Equivalent Device: Nipro Branded Disposable Syringes (K944355) S807.92 (a)(4) Description of Device: The subject devices can be classified as piston syringes…
Nissho Corp.1994—

Also cleared against K944355: 5 other devices →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K051574Nipro Disposable Syringe with or Without NeedleNipro Medical Corp.200510
K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558Smiths Medical Asd, Inc.20069
K072654Patient Safe SyringeRetractable Technologies, Inc.20070
K060002Ritract Safety SyringeRitract, Ltd.20060

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, K051574 (Nipro Medical Corp., 2005) has gone furthest, with 10 descendants of its own.
  • 5 other devices also cite its predicate K944355.

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?

The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

Indications for use as stated in the FDA summary.

Also cleared against K944355

5 other devices cite the same predicate.

  • K130049Monoject 12ML SyringeNipro Medical Corporation · 2013
  • K091279Nipro Disposable SyringeNipro Medical Corporation · 2009
  • K052474Nipro Hypodermic NeedleNipro Medical Corp. · 2005
  • K051574Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
  • K013293Nipro Hypodermic NeedleNipro Medical Corp. · 2001

More from Nipro Medical Corp.

27 FDA decisions under this applicant name. See the company

  • K093985Nipro Safetouch Locktail Safety Fistula NeedleNipro Medical Corp. · 2010
  • K081210Nipro Safetouch Huber Infustion SetNipro Medical Corp. · 20081 recall
  • K072024Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693Nipro Medical Corp. · 20071 recall
  • K063368Nipro Biohole NeedleNipro Medical Corp. · 2007
  • K063721Nipro Safetouch II GammaNipro Medical Corp. · 2007

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/K030683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030683: Nipro Disposable Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030683

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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