Atlas FDA

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

Fortune Medical Instrument Corp. · Predicate Candidate Screening

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

175 daysmedian FDA review time
303 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022112FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020Fortune Medical Instrument Corp.2003-04-032790
K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300Fortune Medical Instrument Corp.2003-02-123030
K021142ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 48Fortune Medical Instrument Corp.2002-10-011750
K014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument Corp.2002-03-04900
K980917ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAFortune Medical Instrument Corp.1998-05-27770
K980919ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATONFortune Medical Instrument Corp.1998-03-31200

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