NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS— 510(k) K132734
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K132734 for NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS, Substantially Equivalent on 2013-10-08. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Round Lake, IL, US
Recent devices under product code FPA
view all- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Baxter Healthcare Corp
view all- K190910 — PrisMax System Version 2
- K163530 — PrisMax Control Unit
- K130531 — ULTRAFUSE
- K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
- K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K132734
K-number listed on FDA's recall record- Z-1102-2021 — Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use.
- Z-0132-2016 — ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132734.
Data sourced from openFDA. This site is unofficial and independent of the FDA.