510(k) Report

510(k) · Cleared

Cleared

Ulticare Disposable Syringe 3 ML/CC

K033794510(k) SpecialCleared Dec 30, 200325-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

Ultimed, Inc. · FMF Syringe, Piston

Cleared on Dec 30, 2003 as substantially equivalent to K994230 (Ultimed, Inc., 2000) and 1 other predicate after a 25-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.

Decided
Dec 30, 2003
Review
25 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K941095 (1994). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2006: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2016: 1 descendant cleared2008: 1 descendant clearedK941095 · Medsaver Syringe · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 5 descendants K941095 · Medsaver Syringe · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19940
  1. Root · 1 generation backK941095 Medsaver SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
  2. This deviceK033794 Ulticare Disposable Syringe 3 ML/CCUltimed, Inc. · 2003
  3. Descendant · cites it directly · 6 of its ownK062702 Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 5 of its ownK070917 Feel-Ject Insulin SyringeFeel Tech · 2007 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK091474 Easy.Touch Insulin SyringeMasters Healthcare, LLC · 2009
  6. Descendant · 3 generations on · 0 of its ownK152803 Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd. · 2016
  7. Descendant · 3 generations on · 0 of its ownK122787 Comfort EZSimple Diagnostics, Inc. · 2012

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12009: 12010: 12012: 12016: 1
2006high 1 (2006) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · See all
  • K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 2006 · cites it directly6descendants
  • K070917Feel-Ject Insulin SyringeFeel Tech · 2007 · 2 generations on5descendants
  • K091474Easy.Touch Insulin SyringeMasters Healthcare, LLC · 2009 · 3 generations on1descendant
  • K152803Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd. · 2016 · 3 generations on0descendants
  • K122787Comfort EZSimple Diagnostics, Inc. · 2012 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941095Medsaver SyringeBd Becton Dickinson Vacutainer Systems Preanalytic1994—
0 (this device)K033794Ulticare Disposable Syringe 3 ML/CCUltimed, Inc.2003—
+1K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc.20061
+2K070917Feel-Ject Insulin SyringeFeel Tech20071
+3K091474Easy.Touch Insulin SyringeMasters Healthcare, LLC2009—
+3K152803Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd.2016—
+3K122787Comfort EZSimple Diagnostics, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
200910
201010
201210
201610
FIG. 1 — Lineage of K033794, 1994–2016Source: 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? (2)

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
*K994230Ulticare Disposable Syringe
Summary page 1
…3 ml Disposable Syringe is substantially equivalent in intended use, function and basic composition to the currently marketed Ulti Med UltiCare I ml Disposable Syringe, K994230, and to the Becton Dickinson Medsaver TM Syringe, K941095. Device Description The UltiCare 3 ml Disposable Syringe is a standard…
Ultimed, Inc.2000—
*K941095Medsaver Syringe
Summary page 1
…tended use, function and basic composition to the currently marketed Ulti Med UltiCare I ml Disposable Syringe, K994230, and to the Becton Dickinson Medsaver TM Syringe, K941095. Device Description The UltiCare 3 ml Disposable Syringe is a standard piston type hypodermic syringe, with a black colored prote…
Bd Becton Dickinson Vacutainer Systems Preanalytic1994—

Also cleared against K994230: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc.20066

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K062702 (Ultimed, Inc., 2006) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K994230.

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 UltiCare Disposable Syringe is used to draw a quantity of pharmaceutical from

its container and allow administration of the pharmaceutical directly to the patient. As

an alternative use the product will allow administration of the pharmaceutical to the

patient via an intravenous port, heparin lock, or saline lock.

Indications for use as stated in the FDA summary.

Also cleared against K994230

1 other device cites the same predicate.

  • K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 20061 recall

More from Ultimed, Inc.

8 FDA decisions under this applicant name. See the company

  • K100812Ulticare Disposable Pen NeedlesUltimed, Inc. · 2010
  • K080600Ultimed Ulticare Safety SyringeUltimed, Inc. · 2008
  • K081449Ultiguard Home Insulin Pen Needle Dispenser and Sharps ContainerUltimed, Inc. · 2008
  • K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 20061 recall
  • K050464Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2Ultimed, Inc. · 2005

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/K033794 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033794: Ulticare Disposable Syringe 3 ML/CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033794

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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