BD Syringe NRFit Lok and BD Syringe NRFit Slip
FDA 510(k) clearance K192538 · decided 2020-09-04
Clearance details
- K-number
- K192538
- Device name
- BD Syringe NRFit Lok and BD Syringe NRFit Slip
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2019-09-16
- Decision date
- 2020-09-04
- Days to decision
- 354 days
- Clearance type
- Traditional
- Product code
- QEH
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Becton
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Omnifix Syringe NRFit (K241385) | B.Braun Medical, Inc. | 2024-07-13 |
| Artiglass NRFitTM Tip L.O.R. Glass Syringes (K213800) | Artiglass Srl | 2022-05-19 |
| NRFit® Caps, Male and Female Neuraxial Tip Caps (K201031) | International Medical Industries, Inc. | 2020-12-16 |
| NRFit Syringe (K181374) | Jiangsu Caina Medical Co.,Ltd | 2018-12-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BD Onclarity HPV Assay (P160037/S024) | Becton, Dickinson and Company | 2026-04-02 |
| BD Onclarity HPV Assay (P160037/S025) | Becton, Dickinson and Company | 2026-04-02 |
| BD FOX PCR Extraction Tubes; BD Onclarity HPV Assay (P160037/S026) | Becton, Dickinson and Company | 2026-02-12 |
| BD ONCLARITY HPV ASSAY (P160037/S022) | Becton, Dickinson and Company | 2025-08-25 |
| BD Onclarity HPV Assay (P160037/S023) | Becton, Dickinson and Company | 2025-07-02 |
| Onclarity HPV Assay (P160037/S021) | Becton, Dickinson and Company | 2025-03-12 |
| BD Onclarity HPV Assay (P160037/S020) | Becton, Dickinson and Company | 2024-11-05 |
| BD Onclarity HPV Assay (P160037/S017) | Becton, Dickinson and Company | 2024-05-14 |