Atlas FDA

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

Sil-Med Corp. — Predicate Candidate Screening

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

73 daysmedian FDA review time
463 days90th percentile
29clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972521NAVIGATOR (STYLET) 2006Sil-Med Corp.1997-10-01860
K961392ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGSil-Med Corp.1997-07-184630
K961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAINSil-Med Corp.1996-08-081340
K961295SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TSil-Med Corp.1996-06-26830
K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.1996-03-11600
K955463GRIP-A-BOOTSSil-Med Corp.1996-01-23550
K942709MEDIASTINAL SILICONE DRAINSSil-Med Corp.1996-01-045750
K926496SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAINSil-Med Corp.1995-05-248760
K926495SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPESil-Med Corp.1994-02-024000
K926408SIL-SLIP FLAT SUCTION DRAINSil-Med Corp.1994-02-024080
K921424SIL-MED FLAT SUCTION DRAINSil-Med Corp.1992-09-281880
K903989SIL-MED T-TUBE DRAINSil-Med Corp.1991-01-311550
K891471SIL-MED WASTE FLUID DUMP BAGSil-Med Corp.1989-08-151530
K885167TRUDELL BENT CATHETERSil-Med Corp.1989-01-31490
K862767SILICONE SUMP DRAINSil-Med Corp.1986-08-07160
K854418ROUND SUCTION DRAINSil-Med Corp.1985-11-19150
K851195VASCULAR ACCESS CATHETERSil-Med Corp.1985-06-07730
K851196INCISION DRAINSil-Med Corp.1985-06-04700
K851921Y CONNECTORSil-Med Corp.1985-05-17150
K850247PERITONEAL DIALYSIS COIL CATHETERSil-Med Corp.1985-02-14230
K843575DERBYSHIRE DRAINSil-Med Corp.1984-10-24430
K842765SILIMED BREAST FORMSil-Med Corp.1984-08-17320
K833872SAV-A-LIMBSil-Med Corp.1984-02-04880
K830607SUCTION RESERVOIRSil-Med Corp.1983-05-02660
K830610FLAT SUCTION DRAINSil-Med Corp.1983-03-29320
K813063FLAT DRAINSil-Med Corp.1981-12-18490
K813062VASCULAR PAWSSil-Med Corp.1981-12-14450
K810080VASCULAR TIE (VAS-TIE)Sil-Med Corp.1981-04-02790
K801818TENCKHOFF CATHETERSil-Med Corp.1980-10-23840

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