510(k) · Cleared
Recalled · 2009Feel-Ject Insulin Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Feel Tech · FMF Syringe, Piston
Cleared on Jun 20, 2007 as substantially equivalent to K062702 (Ultimed, Inc., 2006) after a 79-day review. Its family tree reaches back 3 generations to 1994. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 20, 2007
- Review
- 79 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941657 (1994). 7 ancestors in all. 5 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- 2 generations backK024112 BD Insulin SyringeBecton, Dickinson & CO · 2003 · Recalled
- 1 generation backK062702 Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 2006 · Recalled
- This deviceK070917 Feel-Ject Insulin SyringeFeel Tech · 2007
- Descendant · cites it directly · 1 of its ownK091474 Easy.Touch Insulin SyringeMasters Healthcare, LLC · 2009
- Descendant · cites it directly · 0 of its ownK152803 Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK122787 Comfort EZSimple Diagnostics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK102178 Easy TouchMhc Medical Products · 2010
- Descendant · cites it directly · 0 of its ownK081547 Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K091474Easy.Touch Insulin SyringeMasters Healthcare, LLC · 2009 · cites it directly1descendant
- K152803Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd. · 2016 · cites it directly0descendants
- K122787Comfort EZSimple Diagnostics, Inc. · 2012 · cites it directly0descendants
- K102178Easy TouchMhc Medical Products · 2010 · cites it directly0descendants
- K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941657 | BD Micro Fine, Ultra Fine, and Allergy Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| −2 | K024112 | BD Insulin Syringe | Becton, Dickinson & CO | 2003 | 3 |
| −1 | K062702 | Ulticare Disposable Syringes and Needles | Ultimed, Inc. | 2006 | 1 |
| 0 (this device) | K070917 | Feel-Ject Insulin Syringe | Feel Tech | 2007 | — |
| +1 | K091474 | Easy.Touch Insulin Syringe | Masters Healthcare, LLC | 2009 | — |
| +1 | K152803 | Sungshim Sterile Single Use Insulin Syringe | Sung Shim Medicare Co., Ltd. | 2016 | — |
| +1 | K122787 | Comfort EZ | Simple Diagnostics, Inc. | 2012 | — |
| +1 | K102178 | Easy Touch | Mhc Medical Products | 2010 | — |
| +1 | K081547 | Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC | Bio-Med USA, Inc. | 2008 | — |
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 |
|---|---|---|
| 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 16.2 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062702 | Ulticare Disposable Syringes and NeedlesSummary page 1…860 Class of device: Class 11. 2. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] UltiCareTM Disposable Syringes and Needles K062702 manufactured by Ulti Med Inc. 3. Description of device: The Feel-ject insulin syringe consists of a calibrated hollow barrel… | 2006 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2009 | Not classified | Z-1504-2009 | Nonconforming Material/Component | Needles separate from the barrel of the syringes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K091474 (Masters Healthcare, LLC, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Feel-tech disposable sterile insulin syringes are intended for injection of U100 insulin
only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070917 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070917: Feel-Ject Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070917
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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