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

Boston Pacific Medical, Inc. · Predicate Candidate Screening

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

350 daysmedian FDA review time
539 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K9331094SURE URO-LINK UROLOGICAL PROCEDURE TRAYSBoston Pacific Medical, Inc.1994-03-282760
K9224024 SURE TM ENTERAL FEEDING BAGBoston Pacific Medical, Inc.1994-03-256730
K9310484-SURE NELATON CATHETERBoston Pacific Medical, Inc.1994-02-143500
K9310474-SURE FEMALE CATHETERBoston Pacific Medical, Inc.1994-02-143500
K9218524 SURE TM RECTAL TUBEBoston Pacific Medical, Inc.1993-10-085390
K9218534 SURE TM FEEDING TUBESBoston Pacific Medical, Inc.1993-07-134520
K9218514 SURE TM SUCTION CATHETERS & KITSBoston Pacific Medical, Inc.1993-07-074460
K9223984 SURE TM ENEMA BAG SETBoston Pacific Medical, Inc.1993-06-173920
K9223974 SURE TM NASAL OXYGEN CANNULABoston Pacific Medical, Inc.1993-03-183010
K9249954 SURE TM ANESTHESIA EXTENSION SETBoston Pacific Medical, Inc.1992-12-30900
K9224014 SURE TM COLOSTOMY POUCHBoston Pacific Medical, Inc.1992-06-10200

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