510(k) · Cleared
Recalled · 2010Ulticare Disposable Syringes and Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultimed, Inc. · FMF Syringe, Piston
Cleared on Nov 29, 2006 as substantially equivalent to K994230 (Ultimed, Inc., 2000) and 2 other predicates after a 79-day review. Its family tree reaches back 2 generations to 1994. 6 later devices descend from it. It has been recalled once.
- Decided
- Nov 29, 2006
- Review
- 79 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K941657 (1994). 6 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- 1 generation backK024112 BD Insulin SyringeBecton, Dickinson & CO · 2003 · Recalled
- This deviceK062702 Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK070917 Feel-Ject Insulin SyringeFeel Tech · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK091474 Easy.Touch Insulin SyringeMasters Healthcare, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK152803 Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK122787 Comfort EZSimple Diagnostics, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK102178 Easy TouchMhc Medical Products · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K070917Feel-Ject Insulin SyringeFeel Tech · 2007 · cites it directly5descendants
- K091474Easy.Touch Insulin SyringeMasters Healthcare, LLC · 2009 · 2 generations on1descendant
- K152803Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd. · 2016 · 2 generations on0descendants
- K122787Comfort EZSimple Diagnostics, Inc. · 2012 · 2 generations on0descendants
- K102178Easy TouchMhc Medical Products · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941657 | BD Micro Fine, Ultra Fine, and Allergy Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| −1 | K024112 | BD Insulin Syringe | Becton, Dickinson & CO | 2003 | 3 |
| 0 (this device) | K062702 | Ulticare Disposable Syringes and Needles | Ultimed, Inc. | 2006 | — |
| +1 | K070917 | Feel-Ject Insulin Syringe | Feel Tech | 2007 | 1 |
| +2 | K091474 | Easy.Touch Insulin Syringe | Masters Healthcare, LLC | 2009 | — |
| +2 | K152803 | Sungshim Sterile Single Use Insulin Syringe | Sung Shim Medicare Co., Ltd. | 2016 | — |
| +2 | K122787 | Comfort EZ | Simple Diagnostics, Inc. | 2012 | — |
| +2 | K102178 | Easy Touch | Mhc Medical Products | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
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 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994230 | Ulticare Disposable SyringeSummary page 1…re substantially equivalent in intended use, function and basic composition to the currently marketed UltiCare Low Dead Space Disposable Syringe (1 mI/cc x 22 G x 1.5"), K994230, and to the UltiCare Disposable Syringe (3 ml/cc, 22 G x 1.5"), K033794. The Insulin Syringes are substantially equivalent in in… | 2000 |
| * | K033794 | Ulticare Disposable Syringe 3 ML/CCSummary page 1…ion to the currently marketed UltiCare Low Dead Space Disposable Syringe (1 mI/cc x 22 G x 1.5"), K994230, and to the UltiCare Disposable Syringe (3 ml/cc, 22 G x 1.5"), K033794. The Insulin Syringes are substantially equivalent in intended use, function and basic composition to the currently marketed Bec… | 2003 |
| * | K024112 | BD Insulin SyringeSummary page 1…stantially equivalent in intended use, function and basic composition to the currently marketed Becton Dickinson BD Insulin Syringes - Ultra-FineTM and Ultra-FineTNM II, K0241 12. Device Description The UltiCarc Disposable Syringes and Needles and Insulin Syringes are standard piston type syringcs xvith pe… | 2003 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070917 | Feel-Ject Insulin Syringe | 2007 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 5, 2010 | Not classified | Z-1217-2010 | Employee error | UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe Live Better because it is mislabeled and actually contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K070917 (Feel Tech, 2007) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K994230.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Insulin Syringes (0.3 to 1.0 cc) are intended for subcutaneous injection of U-100 insulin.
The UltiCare disposable syringes and needles (0.3 to 3.0 cc) are 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062702: Ulticare Disposable Syringes and Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062702
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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