Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Bissell Medical Products, Inc. · Predicate Candidate Screening

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

103 daysmedian FDA review time
723 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932880GRASSI GASTROJEJUNOSTOMY TUBEBissell Medical Products, Inc.1995-06-077230
K914140GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEEDBissell Medical Products, Inc.1992-03-311970
K901683IMPROVED BAKER TWIN-CUFF SUMP TUBEBissell Medical Products, Inc.1990-06-27780
K873441BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBEBissell Medical Products, Inc.1987-10-27610
K871691MODIFIED MULTI-LUMEN NASOGASTRIC TUBEBissell Medical Products, Inc.1987-08-101030
K851672NYHUS/NELSON TUBEBissell Medical Products, Inc.1985-07-09770

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