Atlas FDA

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

Medical Restraints, Inc. · Predicate Candidate Screening

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

33 daysmedian FDA review time
35 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K771630LIMB RESTRAINTMedical Restraints, Inc.1977-09-30350
K771629HAND RESTRAINTMedical Restraints, Inc.1977-09-30350
K771636BODY RESTRAINTMedical Restraints, Inc.1977-09-30350
K771632FINGER MITT RESTRAINTMedical Restraints, Inc.1977-09-28330
K771635FOOT ELEVATORMedical Restraints, Inc.1977-09-28330
K771634VEST RESTRAINTMedical Restraints, Inc.1977-09-28330
K771715PELVIC WHEELCHAIR RESTRAINTMedical Restraints, Inc.1977-09-28160
K771676FOOT DROP BOOTMedical Restraints, Inc.1977-09-20180
K771631WHEELCHAIR SAFETY BELTMedical Restraints, Inc.1977-09-12170
K771633HEEL PROTECTORMedical Restraints, Inc.1977-09-12170

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