510(k) Report

510(k) · Cleared

Cleared

Piston Syringe

K951871510(k) TraditionalCleared Jun 21, 199561-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

Baxa Corp. · FMF Syringe, Piston

Cleared on Jun 21, 1995 after a 61-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 40 devices in its family, counting itself, has a Class I recall. 39 later devices descend from it.

Decided
Jun 21, 1995
Review
61 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

39 later devices descend from it, 2 citing it directly. 1 of the 40 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2009: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2017: 5 descendants cleared2021: 6 descendants cleared2015: 2 descendants cleared2022: 2 descendants cleared2016: 7 descendants cleared2026: 2 descendants cleared2018: 3 descendants cleared2020: 3 descendants cleared2019: 2 descendants cleared, 1 with a Class I recall12023: 3 descendants cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951871 Piston SyringeBaxa Corp. · 1995
  2. Descendant · cites it directly · 37 of its ownK092908 Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO…Neomed, Inc. · 2010
  3. Descendant · 2 generations on · 36 of its ownK122373 Neomed Oral/Enteral SyringeNeomed, Inc. · 2012
  4. Descendant · 3 generations on · 34 of its ownK143344 NeoMed NeoConnect Enteral Syringes with ENFit ConnectorNeomed, Inc. · 2015
  5. Descendant · 4 generations on · 30 of its ownK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
  6. Descendant · 5 generations on · 21 of its ownK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12012: 12015: 22016: 72017: 52018: 32019: 22020: 32021: 62022: 22023: 32025: 12026: 2
2009high 7 (2016) · low 0 (2011)2026

Class I recalls in this family

  • K190502 ENFit Oral / Enteral Syringe6 generations on · 2019

Most influential descendants

Showing 5 of 39 · See all
  • K092908Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO…Neomed, Inc. · 2010 · cites it directly37descendants
  • K122373Neomed Oral/Enteral SyringeNeomed, Inc. · 2012 · 2 generations on36descendants
  • K143344NeoMed NeoConnect Enteral Syringes with ENFit ConnectorNeomed, Inc. · 2015 · 3 generations on34descendants
  • K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc. · 2015 · 4 generations on30descendants
  • K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Neomed, Inc. · 2016 · 5 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951871Piston SyringeBaxa Corp.1995—
+1K092908Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO…Neomed, Inc.2010—
+2K122373Neomed Oral/Enteral SyringeNeomed, Inc.2012—
+3K143344NeoMed NeoConnect Enteral Syringes with ENFit ConnectorNeomed, Inc.2015—
+4K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible…Neomed, Inc.2015—
+5K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and…Neomed, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201210
201520
201670
201750
201830
201921
202030
202160
202220
202330
202510
202620
FIG. 1 — Lineage of K951871, 1995–2026Source: 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.

1 device in this family has a Class I recall. 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?

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

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K092908Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO…Neomed, Inc.201037
K092986Acacia Piston SyringeAcacia, Inc.20090

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

  • Of its descendants, K092908 (Neomed, Inc., 2010) has gone furthest, with 37 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 Baxa Corp.

8 FDA decisions under this applicant name. See the company

  • K090917Sureconnect Closed Drug Reconstitution and Transfer SystemBaxa Corp. · 2010
  • K070163Swabbable Cap, Model 60205Baxa Corp. · 2007
  • K062909Repeater Pump II Tube SetsBaxa Corp. · 2007
  • K022523Rapid-Fill Tubeset, Model 90005Baxa Corp. · 2002
  • K002705Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. · 20016 Class I recalls

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/K951871 · printed Nov 5, 2026

Cite this page

510(k) Report. “K951871: Piston Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951871

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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