510(k) · Cleared
ClearedOmnifix Syringe NRFit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Cleared on Jul 13, 2024 as substantially equivalent to K071459 (B.Braun Medical, Inc., 2007) after a 59-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jul 13, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- QEH
- 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 deviceK241385 Omnifix Syringe NRFitB.Braun Medical, Inc. · 2024
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) | K241385 | Omnifix Syringe NRFit | B.Braun Medical, Inc. | 2024 | — |
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 QEH? 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 QEH device
- #1 K213800 Artiglass NRFitTM Tip L.O.R. Glass Syringesscore 3.7 · 2 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…: Piston Syringe Device Class: 2 Product Code: QEH Predicate Device 510(k) Number: K071459 Device Trade Name: B. Braun Piston Syringes Common Name: Piston Syringe Classificatio… | 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 30 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 QEH devicesQEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QEH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEH
Too few QEH 510(k)s in any year since 2007 to give a median.
Recalls per year · QEH
No recall names QEH since 2007.
Adverse event reports per year · QEH
5in 2025
MAUDE reports naming product code QEH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healthcare professionals in healthcare facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241385: Omnifix Syringe NRFit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241385
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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