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

Hoffrel Instruments, Inc. — Predicate Candidate Screening

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

109 daysmedian FDA review time
189 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K870850MOD 482Hoffrel Instruments, Inc.1987-09-081890
K860235MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCERHoffrel Instruments, Inc.1986-05-151130
K850165MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417Hoffrel Instruments, Inc.1985-10-232800
K844916MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLERHoffrel Instruments, Inc.1985-04-221250
K834276MOD 456Hoffrel Instruments, Inc.1984-02-171090
K834277MOD 427Hoffrel Instruments, Inc.1984-02-171090
K837282MODEL VPS VASCULAR PROFILE SYSTEMHoffrel Instruments, Inc.1983-04-26420
K837229TRANSDUCER MODELS 450, 451, 452, 453, 454Hoffrel Instruments, Inc.1983-04-15450
K837142TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEMHoffrel Instruments, Inc.1983-03-23790
K800364ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202Hoffrel Instruments, Inc.1980-03-12210
K790396ULTRASONIC DIAGNOSTIC SYSTEMHoffrel Instruments, Inc.1979-03-21230
K780651ULTRASONIC DIAGNOSTIC TRANSDUCERHoffrel Instruments, Inc.1978-05-09200

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