Atlas FDA

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

Heelbo, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
88 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K980640HEELBO WAIST AND CHEST VESTHeelbo, Inc.1998-05-01710
K963372HEELBO ER WRIST RESTRAINTHeelbo, Inc.1996-11-07720
K963060HEELBO SECURITY BELTHeelbo, Inc.1996-11-04890
K963099HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKETHeelbo, Inc.1996-11-01840
K963041HEELBO LIFE JACKET WITH CROTCH SUPPORTHeelbo, Inc.1996-10-31870
K962832HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAPHeelbo, Inc.1996-10-18880
K962831THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSUREHeelbo, Inc.1996-10-18880
K962834HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASEHeelbo, Inc.1996-10-18880
K962839HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAPHeelbo, Inc.1996-10-18880
K963294HEELBO WRAP AROUND VESTHeelbo, Inc.1996-10-11510
K963237HEELBO ICU 911 BLAZER SLEEVED JACKETHeelbo, Inc.1996-10-09510
K962778THE L-BOW ARM RESTRAINTHeelbo, Inc.1996-10-09840
K962810GREAT HANDS MITTSHeelbo, Inc.1996-10-09830
K963243HEELBO BLAZER SLEEVED JACKETHeelbo, Inc.1996-10-01430

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