510(k) · Cleared
ClearedBD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · FMF Syringe, Piston
Cleared on Dec 19, 2016 as substantially equivalent to K941562 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) and 3 other predicates after a 145-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Dec 19, 2016
- Review
- 145 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K931367 (1993). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 1 generation backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- This deviceK162081 BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic…Becton, Dickinson and Company · 2016
- Descendant · cites it directly · 0 of its ownK222852 Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −1 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| 0 (this device) | K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with… | Becton, Dickinson and Company | 2016 | — |
| +1 | K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | Nipro Medical Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K941562 | 1ML Luer-Lok SyringeSummary page 6…ode: FMF (Syringe, Piston) Predicate Devices: Trade Name: BD 1mL Luer-Lok™ Hypodermic Syringe 510(k) Reference: K941562 Common Name: Piston Syringe Classification: Class II device, 21… | 1994 |
| * | K021475 | BD Single Lumen Needle, Syringe and Blood Collection SetSummary page 6…Product Code: FMF (Syringe, Piston) Trade Name: BD Hypodermic Needle 510(k) Reference: K021475 Common Name: Hypodermic Needle Classification: Class II, 21 CFR… | 2002 |
| * | K161170 | BD Eclipse Hypodermic NeedleSummary page 6…FMI (Needle, Hypodermic, Single Lumen) Trade Name: BD Eclipse™ Hypodermic Needle 510(k) Reference: K161170 Common Name: Hypodermic Needle Classification: Class II, 21 CFR… | 2016 |
| * | K024112 | BD Insulin SyringeSummary page 7…n) Trade Name: BD 1mL Luer-Lok™ Insulin Syringe 510(k) Reference: K024112 Common Name: Piston Syringe Classification:… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | 2023 | 0 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 14.4 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K222852 (Nipro Medical Corporation, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K941562.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle is intended for use by health care professionals for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse™ Hypodermic Needle contains a…
Read the full statement (114 words)
The BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle is intended for use by health care professionals for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin.
The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
The BD 1mL Luer-Lok™ Insulin Syringe is intended for subcutaneous injection of U-100 insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162081: BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162081
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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