LOW PROFILE SAFSITE Y-SITE
FDA 510(k) clearance K954123 · decided 1995-11-21
Clearance details
- K-number
- K954123
- Device name
- LOW PROFILE SAFSITE Y-SITE
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-01
- Decision date
- 1995-11-21
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADDitIV utilized in gravity IV administration sets and pump administration sets utilized w recall (Z-0605-2026) | B Braun Medical Inc | 2025-11-26 |
| Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Acce recall (Z-0091-2023) | B. Braun Medical, Inc. | 2022-10-14 |
| SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device us recall (Z-0987-2014) | B. Braun Medical, Inc. | 2014-02-18 |
| Outlook Pump IV Set with Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, Sp recall (Z-0704-2010) | B. Braun Medical, Inc. | 2010-01-26 |
| Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lo recall (Z-0705-2010) | B. Braun Medical, Inc. | 2010-01-26 |