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

Bowen & Company, Inc. · Predicate Candidate Screening

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

21 daysmedian FDA review time
117 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K896898BOWEN ELECTRODE SKIN PREPATORY CLEANSERBowen & Company, Inc.1990-04-041170
K896538DISPOSABLE 45 DEGREE SHAVERBowen & Company, Inc.1989-12-06200
K873766STERNAL POWER AWLBowen & Company, Inc.1988-11-144250
K872098CREMEEN ALVEOLAR BONE CALIPERBowen & Company, Inc.1987-07-31600
K871325BOWEN REUSEABLE/DISPOSABLE ELECTRODEBowen & Company, Inc.1987-06-08660
K87088245 DEGREE SHAVERBowen & Company, Inc.1987-03-23180
K870881LOOSE BODY GRASPERSBowen & Company, Inc.1987-03-23180
K863149BOWEN PROBEBowen & Company, Inc.1986-09-05210
K863148BOWEN KNOT PASSERBowen & Company, Inc.1986-09-05210
K863150BOWEN CANNULABowen & Company, Inc.1986-09-05210
K863146BOWEN SUTURE PASSERBowen & Company, Inc.1986-09-05210
K863147GLENOID DRILLBowen & Company, Inc.1986-09-05210
K853376MORGAN SUTURE-DRILLBowen & Company, Inc.1985-11-13930
K853601MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASPBowen & Company, Inc.1985-09-16200

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