Atlas FDA

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

Inmed Corp. — Predicate Candidate Screening

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

36 daysmedian FDA review time
147 days90th percentile
32clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K862672ESOPHAGEAL STETHOSCOPE WITH THERMISTORInmed Corp.1986-10-271050
K853162STERILE NASOPHARYNGEAL AIRWAYInmed Corp.1985-08-0670
K850152PRECONNECTED URETHRAL CATHETER TRAYInmed Corp.1985-03-12560
K850335URETEROSCOPY CATHETERInmed Corp.1985-03-12430
K850248DISPOSABLE GUEDEL AIRWAYInmed Corp.1985-03-12490
K844801ULTRA EXTERNAL CATHETERInmed Corp.1985-01-15350
K842301DISPOSABLE LATEX BANDAGEInmed Corp.1984-11-051470
K842866URETHRAL CATHETERIZATION TRAYInmed Corp.1984-09-10490
K841040FOX POST NASAL BALLOON CATHETERInmed Corp.1984-08-171580
K842865ESOPHAGEAL STETHOSCOPEInmed Corp.1984-08-15230
K841037PENROSE DRAINSInmed Corp.1984-04-25440
K841036RECTAL BALLOON CATHETERSInmed Corp.1984-04-13320
K841033MILLER-ABBOTT TUBEInmed Corp.1984-04-13320
K841038BLAKEMORE TUBEInmed Corp.1984-04-13320
K841039CANTOR TUBEInmed Corp.1984-04-13320
K841034DEAVER T-DRAIN & CATTEL T-DRAINInmed Corp.1984-04-13320
K841035ULTRA BAKER JEJUNOSTOMY TUBEInmed Corp.1984-04-13321
K840973COLE TUBE-LATEXInmed Corp.1984-03-30240
K841093NASOPHARYNGEAL AIRWAYSInmed Corp.1984-03-23100
K832363FOLEY CATHETERIZATION TRAY-VARIOUSInmed Corp.1984-03-072330
K834258HODGE DECOMPRESSION TUBEInmed Corp.1984-02-04590
K832859FOAM HELMET - USE W/ESOPHAGEAL TAMPONAInmed Corp.1983-11-14830
K832472ELEVATOR CUSHIONInmed Corp.1983-09-20560
K832389CATHETER CARE TRAYInmed Corp.1983-09-19620
K832471ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN IIIInmed Corp.1983-09-12480
K832672FOUR LUMEN BLAKEMORE TUBEInmed Corp.1983-09-12340
K823475BROOKS SCLEROTHERAPY CUFFInmed Corp.1983-07-122320
K820987FOLEY INSERTION TRAYS W/OVERWRAYInmed Corp.1982-05-13360
K813332BRISTOL BALLON INTRODUCER, MANDRIL SETInmed Corp.1981-12-14200
K813169CELESTIN PULSION ESOPHOGEAL PROSTHESISInmed Corp.1981-12-03210
K813026GUIDE WIREInmed Corp.1981-11-17200
K812289CELESTIN DILATORInmed Corp.1981-09-01190

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