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

Boston Surgical Products, Inc. · Predicate Candidate Screening

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

78 daysmedian FDA review time
161 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972311MODEL 20 BIPOLAR COAGULATORBoston Surgical Products, Inc.1997-09-18900
K972350MODEL 50 BIPOLAR COAGULATORBoston Surgical Products, Inc.1997-08-21580
K944947ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSBoston Surgical Products, Inc.1995-07-282940
K953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSBoston Surgical Products, Inc.1995-07-12140
K950375DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATORBoston Surgical Products, Inc.1995-06-141340
K951912DISOPOSABLE & RESUABLE MONPOLAR CORDBoston Surgical Products, Inc.1995-05-12180
K951269DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCILBoston Surgical Products, Inc.1995-04-24340
K950877REUSABLE MONOPOLAR FORCEPSBoston Surgical Products, Inc.1995-03-09100
K945171DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECEBoston Surgical Products, Inc.1995-02-081100
K945893DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODEBoston Surgical Products, Inc.1994-12-13110
K944634ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIESBoston Surgical Products, Inc.1994-12-08780
K944642ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIESBoston Surgical Products, Inc.1994-12-08780
K945717ELECTROSURGICAL ENDOSCOPIC CORDBoston Surgical Products, Inc.1994-12-08170
K944578BIPOLAR CORDBoston Surgical Products, Inc.1994-12-08800
K942710DISPOSABLE BIPOLAR COAGULATING FORCEPSBoston Surgical Products, Inc.1994-11-171610
K945299DISPOSABLE & REUSABLE CHUCK HANDLEBoston Surgical Products, Inc.1994-11-0990
K943031BIPOLAR ELECTROSURGICAL PENCILBoston Surgical Products, Inc.1994-09-23880

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