510(k) · Cleared
ClearedOmnifix Low Dead Space Luer Lock Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FMF Syringe, Piston
Cleared on Mar 5, 2020 as substantially equivalent to K071459 (B.Braun Medical, Inc., 2007) after a 118-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Mar 5, 2020
- Review
- 118 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944355 (1994). 8 ancestors in all, the oldest K941657 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 4 generations backK030683 Nipro Disposable SyringesNipro Medical Corp. · 2003
- 3 generations backK051574 Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
- 2 generations backK063280 Injekt SyringeB.Braun Medical, Inc. · 2006 · Recalled
- 1 generation backK071459 B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc. · 2007 · Recalled
- This deviceK193101 Omnifix Low Dead Space Luer Lock SyringeB.Braun Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −4 | K030683 | Nipro Disposable Syringes | Nipro Medical Corp. | 2003 | — |
| −3 | K051574 | Nipro Disposable Syringe with or Without Needle | Nipro Medical Corp. | 2005 | — |
| −2 | K063280 | Injekt Syringe | B.Braun Medical, Inc. | 2006 | 2 |
| −1 | K071459 | B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes | B.Braun Medical, Inc. | 2007 | 2 |
| 0 (this device) | K193101 | Omnifix Low Dead Space Luer Lock Syringe | B.Braun Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K071459 | B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesSummary page 4…es Classification Name: Piston Syringe, 21 CFR §880.5860: Class II, Product code FMF PREDICATE DEVICES: • K071459 B. Braun Omnifix® Piston Syringes DEVICE DESCRIPTION The Omnifix® Low Dead Space (LDS) Luer Lock Syringes consist of a gradu… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K071459.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 B.Braun Omnifix® Low Dead Space Luer Lock Syringes are intended to be used to inject fluid into, or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193101: Omnifix Low Dead Space Luer Lock Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193101
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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