Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Unoplast A/S · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

120 daysmedian FDA review time

386 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K896734	FEEDING TUBE	Unoplast A/S	1990-12-21	386	0
K896729	NELATON-, FEMALE - OR TIEMANN CATHETER	Unoplast A/S	1990-11-05	340	13
K896732	UNOMETER 500	Unoplast A/S	1990-11-02	337	0
K896731	OXYGEN CATHETERS	Unoplast A/S	1990-03-30	120	0
K896730	SUCTION CATHETER STRAIGHT/COUDE	Unoplast A/S	1990-03-30	120	0
K896733	VACCON	Unoplast A/S	1990-02-01	63	0
K802248	DISARP ORIGINAL	Unoplast A/S	1980-09-26	10	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda