DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466— 510(k) K895631
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K895631 for DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466, Substantially Equivalent on 1990-01-29. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code KDJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
Recent devices under product code KDJ
view all- K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch +4 more
- K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A +1 more
- K214016 — 15L Cycler Drainage Bag
- K192705 — MiniCap Extended Life PD Transfer Sets
- K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
More clearances from Baxter Healthcare Corp
view all- K190910 — PrisMax System Version 2
- K163530 — PrisMax Control Unit
- K130531 — ULTRAFUSE
- K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
- K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
Adverse events under product code KDJ
product code KDJ- Death
- 298
- Injury
- 9,221
- Malfunction
- 8,438
- Other
- 1
- Total
- 17,958
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 K895631
K-number listed on FDA's recall record- Z-1269-2015 — MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
- Z-2074-2014 — Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
- Z-1945-2014 — Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
- Z-1565-2013 — Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K895631.
Data sourced from openFDA. This site is unofficial and independent of the FDA.