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

Beacon Laboratories, Inc. — Predicate Candidate Screening

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

77 daysmedian FDA review time
245 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K930243FLEXIBLE EXTENDERBeacon Laboratories, Inc.1994-03-114160
K930497ARGON HANDPIECESBeacon Laboratories, Inc.1993-06-251440
K925708DISPOSABLE ELECTROSURGERY BALL ELECTRODEBeacon Laboratories, Inc.1993-04-201590
K922289SESQUIPOLAR(TM) MIS ELECTRODEBeacon Laboratories, Inc.1993-01-152450
K925619DISPOSABLE HAND-SWITCHING ESU PENCILBeacon Laboratories, Inc.1992-12-24480
K915788MIS ELECTROSURGICAL ELECTRODESBeacon Laboratories, Inc.1992-03-13800
K920100GSU HANDPIECE ADAPTERBeacon Laboratories, Inc.1992-02-03250
K913772PRESSURE GUARDBeacon Laboratories, Inc.1991-11-19880
K905752ARGON BEAM COMBO LAPAROSCOPIC ELECTRODEBeacon Laboratories, Inc.1991-07-222100
K904506ACTIVE ADAPTERBeacon Laboratories, Inc.1990-12-13720
K902996ARGON BEAM LAPAROSCOPIC ELECTRODEBeacon Laboratories, Inc.1990-11-211350
K903724BEAMER 1,2,4,6, AND 8Beacon Laboratories, Inc.1990-09-28430
K902035FLEXIBLE EXTENDERBeacon Laboratories, Inc.1990-07-19770
K900767B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECEBeacon Laboratories, Inc.1990-05-04770
K901248ABC HANDPIECE ADAPTERBeacon Laboratories, Inc.1990-04-03190
K894663BEAMER ONEBeacon Laboratories, Inc.1989-09-15530
K894762B100 DISPOSABLE HANDPIECEBeacon Laboratories, Inc.1989-09-15500
K894602B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)Beacon Laboratories, Inc.1989-08-09200

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