Atlas FDA

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

Porges Corp. — Predicate Candidate Screening

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

75 daysmedian FDA review time
82 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K900269PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGEPorges Corp.1990-07-031660
K900031MODIFIED PEDIATRIC SILICONE FOLEY CATHETERSPorges Corp.1990-03-06610
K896503PORGES ERCP CATHETERSPorges Corp.1990-01-30760
K896505PORGES UNIVERSAL HANDLESPorges Corp.1990-01-30760
K896425PORGES CYTOLOGY BRUSHESPorges Corp.1990-01-29820
K896507PORGES DIATHERMY SNAREPorges Corp.1990-01-29750
K896504PORGES 2-WAY BALLOON EXTRACTION CATHETERPorges Corp.1990-01-26720
K896506PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTORPorges Corp.1990-01-26720
K896424PORGES SCLEROTHERAPY NEEDLESPorges Corp.1990-01-26790
K896423PORGES BILIARY STENTSPorges Corp.1990-01-22750
K896502PORGES BIOPSY & FOREIGN BODY FORCEPSPorges Corp.1990-01-22680
K896426PORGES SPHINCTEROTOMESPorges Corp.1990-01-22750
K896376PORGES NASOBILIARY DRAINPorges Corp.1990-01-22770
K896537PORGES HOT BIOPSY FORCEPSPorges Corp.1989-11-30150
K892383BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SETPorges Corp.1989-05-04280
K892384BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETERPorges Corp.1989-05-04280
K883526PORGES STEPPED NEOPLEX DILATORPorges Corp.1988-10-28710
K881097SPEC 5* SUPRAPUBIC CATHETERPorges Corp.1988-06-03800

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