510(k) · Cleared
ClearedBD Micro Fine, Ultra Fine, and Allergy Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · FMF Syringe, Piston
Cleared on May 26, 1994 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 55 devices in its family, counting itself, has a Class I recall. 54 later devices descend from it.
- Decided
- May 26, 1994
- Review
- 51 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
54 later devices descend from it, 8 citing it directly. 1 of the 55 devices in this family, counting this one, has a Class I recall.
- This deviceK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- Descendant · cites it directly · 37 of its ownK024112 BD Insulin SyringeBecton, Dickinson & CO · 2003 · Recalled
- Descendant · 2 generations on · 10 of its ownK040036 Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical · 2004
- Descendant · 3 generations on · 8 of its ownK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
- Descendant · cites it directly · 7 of its ownK980796 Terumo Allergy SyringeTerumo Corp. · 1998
- Descendant · 2 generations on · 6 of its ownK062702 Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 2006 · Recalled
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K063755 Portex Hypodermic Needle-Pro Fixed Needle Syringe3 generations on · 2007
Most influential descendants
Showing 5 of 54 · See all- K024112BD Insulin SyringeBecton, Dickinson & CO · 2003 · cites it directly37descendants
- K040036Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical · 2004 · 2 generations on10descendants
- K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005 · 3 generations on8descendants
- K980796Terumo Allergy SyringeTerumo Corp. · 1998 · cites it directly7descendants
- K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 2006 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K040036 | Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905 | Inviro Medical | 2004 | — |
| +3 | K050131 | Insosafe Bak'snap Retractable Insulin Safety Syringe | M.K. Meditech Co., Ltd. | 2005 | — |
| +1 | K980796 | Terumo Allergy Syringe | Terumo Corp. | 1998 | — |
| +2 | K062702 | Ulticare Disposable Syringes and Needles | Ultimed, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 1 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (54)
See all 548 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024112 | BD Insulin Syringe | 2003 | 37 |
| K980796 | Terumo Allergy Syringe | 1998 | 7 |
| K091167 | Shina Insulin Syringe-Including Accu-Sure Insulin Syringes | 2009 | 4 |
| K170386 | BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes… | 2017 | 3 |
| K123588 | Intradermal Adapter | 2013 | 3 |
| K021993 | Shanchuan Syringe | 2003 | 1 |
| K962084 | Omnican Syringe | 1997 | 1 |
| K052551 | Devon Standard Syringe, Hypodermic Needle and Insulin Syringe | 2005 | 0 |
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.
- K063755Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K024112 (Becton, Dickinson & CO, 2003) has gone furthest, with 37 descendants 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.
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) | — |
https://510kreport.com/device/K941657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941657: BD Micro Fine, Ultra Fine, and Allergy Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941657
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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