Atlas FDA

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

Holl Meditronics, Inc. · Predicate Candidate Screening

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

203 daysmedian FDA review time
545 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954171ARCO-MBC, ARCO MCHoll Meditronics, Inc.1996-04-302380
K942095SONOCA IIIHoll Meditronics, Inc.1994-11-092030
K911600ILCO INFRARED LIGHT COAGULATORHoll Meditronics, Inc.1991-07-09900
K893924MOTO-MED RF-II AND PICOHoll Meditronics, Inc.1990-11-275450
K901737SONOCA II ULTRASONIC SURGICAL DEVICEHoll Meditronics, Inc.1990-07-03770
K893926SONOCA ULTRASONIC SURGICAL SYSTEMHoll Meditronics, Inc.1989-11-141670

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