Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FMQ — Predicate Candidate Screening
134 FDA 510(k) clearances under this product code; the 50 most recent screened below.
72 daysmedian FDA review time
89 days90th percentile
134clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110377 | PROTECTIVE RESTRAINT | Medi-Tech Intl. Corp. | 2011-04-25 | 75 | 0 |
| K081264 | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS | Children'S Health First, Inc. | 2009-02-13 | 284 | 0 |
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | Tri-State Hospital Supply Corp. | 2008-08-28 | 191 | 0 |
| K013239 | COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAG | Med Gen, Inc. | 2001-11-20 | 53 | 0 |
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | Skil-Care Corp. | 2001-05-24 | 66 | 0 |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | Skil-Care Corp. | 2001-05-18 | 74 | 0 |
| K991591 | BIOTHANE PATIENT RESTRAINT | Bioplastics | 1999-07-29 | 83 | 0 |
| K982178 | VAGABOND SOFT RESTRAINT SYSTEM | Emergent Innovations, Ltd. | 1999-01-26 | 218 | 0 |
| K980640 | HEELBO WAIST AND CHEST VEST | Heelbo, Inc. | 1998-05-01 | 71 | 0 |
| K972446 | PEDO CUSH PEDO CUDDLE | Cavity Free Kids, Inc. | 1997-11-13 | 136 | 0 |
| K972046 | FULL BODY RESTRAINT SYSTEM | Gillen Industries | 1997-08-15 | 74 | 0 |
| K971948 | PATIENT RESTRAINT | E.M. Adams Co., Inc. | 1997-08-06 | 70 | 0 |
| K972123 | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | Smith | 1997-07-25 | 50 | 0 |
| K971742 | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT | Depuy, Inc. | 1997-07-24 | 73 | 0 |
| K972338 | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. | Geriatric Products, Inc. | 1997-07-24 | 31 | 0 |
| K971561 | PROVEST-PROTECTIVE RESTRAINT | Jemm Medical Products | 1997-07-14 | 76 | 0 |
| K971536 | RESTRAINTS (VESTS AND JACKETS) | E.M. Adams Co., Inc. | 1997-07-01 | 64 | 0 |
| K970274 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | 1997-04-11 | 78 | 0 |
| K970273 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | 1997-04-11 | 78 | 0 |
| K970275 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | 1997-04-11 | 78 | 0 |
| K970272 | PATIENT RESTRAINT | Fla Orthopedics, Inc. | 1997-04-11 | 78 | 0 |
| K962327 | SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE | Sekure Seat Corp. | 1997-03-06 | 262 | 0 |
| K963466 | PEDIATRIC LIMB HOLDER | Deroyal Industries, Inc. | 1997-02-13 | 163 | 0 |
| K963474 | TUXEDO VEST RESTRAINT | Deroyal Industries, Inc. | 1997-01-22 | 141 | 0 |
| K963468 | RESTRICTIVE LIMB HOLDER | Deroyal Industries, Inc. | 1997-01-22 | 141 | 0 |
| K963476 | DISPOSABLE LIMB HOLDER | Deroyal Industries, Inc. | 1997-01-22 | 141 | 1 |
| K963467 | ROLL BELTS | Deroyal Industries, Inc. | 1997-01-03 | 122 | 0 |
| K963465 | PELVIC HOLDER | Deroyal Industries, Inc. | 1996-12-19 | 107 | 0 |
| K963906 | PATIENT RESTRAINTS | Safety Intl., Inc. | 1996-12-02 | 63 | 0 |
| K963547 | THE WRAP IMMOBILIZATION SYSTEM | Safe Restraints, Inc. | 1996-12-02 | 88 | 0 |
| K963559 | WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) | Tecnol Medical Products, Inc. | 1996-11-22 | 78 | 0 |
| K963421 | PROTECTIVE RESTRAINT (WAIST HOLDER) | Kenad SG Medical, Inc. | 1996-11-22 | 84 | 0 |
| K963485 | SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RES | Humane Restraint, Inc. | 1996-11-22 | 80 | 0 |
| K963422 | PROTECTIVE RESTRAINT (PROTECTIVE MITT) | Kenad SG Medical, Inc. | 1996-11-22 | 84 | 0 |
| K963436 | RESTRAINT ACCESSORIES | J. T. Posey Co. | 1996-11-22 | 84 | 22 |
| K963410 | POSEY STRAIGHT JACKETS | J. T. Posey Co. | 1996-11-22 | 84 | 0 |
| K963564 | PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) | Tecnol Medical Products, Inc. | 1996-11-22 | 78 | 0 |
| K963552 | QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) | Tecnol Medical Products, Inc. | 1996-11-22 | 78 | 0 |
| K963430 | PROTECTIVE RESTRAINT (VEST RESTRAINT) | Kenad SG Medical, Inc. | 1996-11-22 | 84 | 0 |
| K963442 | JACKETS AND VESTS | J. T. Posey Co. | 1996-11-22 | 84 | 0 |
| K963414 | MULTIPLE BELTS | J. T. Posey Co. | 1996-11-22 | 84 | 0 |
| K963561 | ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030, | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963462 | COMFOR FOAM LIMB HOLDERS- SINGLE STRAP | Bird & Cronin, Inc. | 1996-11-21 | 79 | 0 |
| K963554 | 24448-010 SECURE-ALL FINGER CONTROL MITT | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963557 | SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453- | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963556 | SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020, | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963563 | ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL( | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963773 | 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY | Tecnol Medical Products, Inc. | 1996-11-21 | 63 | 0 |
| K963439 | PEDIATRIC LIMB HOLDERS | J. T. Posey Co. | 1996-11-19 | 81 | 0 |
| K963411 | POSEY LAPTOP TRAYS | J. T. Posey Co. | 1996-11-19 | 81 | 0 |
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