Atlas FDA

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

Catco Medical, Inc. · Predicate Candidate Screening

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

190 daysmedian FDA review time
210 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945728CATCO THORACIC CATHETERCatco Medical, Inc.1995-05-231820
K944368CATCO SILICONE UMBILICAL VESSEL CATHETERCatco Medical, Inc.1995-04-052100
K944367CATCO POLYURETHANE UMBILICAL VESSEL CATHETERCatco Medical, Inc.1995-04-052100
K944336CATCO UMBILICAL VESSEL CATHETERCatco Medical, Inc.1995-04-052110
K944410CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETERCatco Medical, Inc.1995-04-052090
K944504CATCO FIRST PICCCatco Medical, Inc.1995-03-311980
K944685CATO FIRST PICC-DUAL LUMENCatco Medical, Inc.1995-03-311900
K945012CATCO NUTRITIONAL CATHETERCatco Medical, Inc.1995-02-241340
K945258CATCO URINARY COLLECTION KITCatco Medical, Inc.1995-02-161110
K945499CATO FIRST PICC KITCatco Medical, Inc.1995-02-07901
K945727CATCO NEONATAL PALATE GUARDCatco Medical, Inc.1994-12-07150
K944782CATCO UROLOGICAL CATHETERCatco Medical, Inc.1994-10-13160

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