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

Lifeguard Medical Products, Inc. · Predicate Candidate Screening

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

84 daysmedian FDA review time
147 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K013421LIFEGUARD NASAL CPAP MASK AND ACCESSORIESLifeguard Medical Products, Inc.2002-01-08840
K915296MONOPOLAR ELECTRODELifeguard Medical Products, Inc.1992-09-032930
K920471LEVY ARTICULATING RETRACTORLifeguard Medical Products, Inc.1992-06-231470
K915505REGULATOR FLOWMETERLifeguard Medical Products, Inc.1992-04-221350
K915297TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MMLifeguard Medical Products, Inc.1992-02-11880
K915298SUCTION/IRRIGATION CANNULA; CATLOG #532.00Lifeguard Medical Products, Inc.1992-01-23690
K880958LIFEGUARD BACTERIAL AND VIRAL FILTERLifeguard Medical Products, Inc.1988-04-27510
K880959LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRYLifeguard Medical Products, Inc.1988-04-14380
K881086LIFEGUARD MOUTH TO MASK RESUSCITATORLifeguard Medical Products, Inc.1988-04-14310
K881087LIFEGUARD SINGLE USE MANUAL RESUSCITATORSLifeguard Medical Products, Inc.1988-04-14310
K863711REGULATOR OXYGEN MECHANICALLifeguard Medical Products, Inc.1987-01-271260
K811162FLOWLOCK OXYGEN METERLifeguard Medical Products, Inc.1981-05-08100

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