Atlas FDA

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

BZB · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

66 daysmedian FDA review time
173 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K896731OXYGEN CATHETERSUnoplast A/S1990-03-301200
K843466PHARMA-PLAST OXYGEN CATHETERZimmar Consulting , Ltd.1984-11-19740
K833351DEMAND OXYGEN CONTROLLERHealthdyne, Inc.1984-03-191730
K830984OXYGEN CATHETERSMedovations, Inc.1983-05-18500
K820370NASAL OXYGEN CATHETERAmerican Pharmaseal Div. Ahsc1982-04-16660
K800506OXYGEN CATHETERMedi-Craft , Ltd.1980-03-25210
K791273CONPHAR OXYGEN CATHETER-STERILEConphar, Inc.1979-07-24180
K790057CATHETER, OXYGENMedline Industries, Inc.1979-02-05270

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