Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

IQK — Predicate Candidate Screening

27 FDA 510(k) clearances under this product code; the 50 most recent screened below.

29 daysmedian FDA review time
121 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K930730DORMIE NECK SUPPORT SYSTEMThe Western Diagnostics Co.1993-07-221610
K926291SCHUL-TEC IMMOBILIZERMedical Emergency Support Equipment1993-03-301060
K895477NOVA PILLOWNova Health Systems, Inc.1990-01-101210
K896042MEDICAL DISPOSABLE BEDDINGKeystone Veterinary Supplies, Inc.1990-01-10860
K882264BATTLE CREEK PILLOWBattle Creek Equipment Co.1988-08-09700
K850465CERVICAL COLLARS & HEAD HALTERSAbco Dealers, Inc.1985-04-25870
K832990STIFNICK IMMOBILIZING COLLARLaerdal California, Inc.1983-11-07670
K832001HEAD-IMMOBILIZERInt'L Safety Corp.1983-07-12200
K831582VARI-SUPPORT NECK POSTURE PILLOWBody Therapeutics, Inc.1983-06-15290
K830350CERVICAL PILLOWDeip Enterprises, Inc.1983-03-09340
K830348VINYL EXTRICATION COLLARDeip Enterprises, Inc.1983-03-09340
K830351DISPOSABLE EXTRICATION COLLARDeip Enterprises, Inc.1983-03-09340
K823667CERVICAL COLLARWarm & Form, Orthopedic Materials1982-12-30240
K823247U-WAY QUICKOLLAREms Industries, Inc.1982-11-16150
K823161CERVICAL COLLARWarm & Form, Orthopedic Materials1982-11-10160
K821837VARI-SUPPORT NECK POSTURE PILLOWBody Therapeutics, Inc.1982-07-20280
K820366BECSIC COLLARBlackstone & Breglio Industries1982-03-01200
K812019LOXLEY EMERGENCY CERVICAL COLLARLoxley Medical1981-10-02810
K811298EXECUTIVE COLLAROrthomedics1981-05-27160
K810024BONNER BRACEBee Ent.1981-01-23180
K803147CONPHAR ADJUSTABLE CERVICAL COLLARConphar, Inc.1981-01-08270
K802442LOW BACK POSTURE PILLOWBody Therapeutics, Inc.1980-10-31240
K801628RESTRAINT, PROTECTIVEThe Owenby Co.1980-08-07230
K800108BASHAW CERVICAL IMMOBILIZER DEVICEBashaw Custom Specialties, Inc.1980-02-29440
K780994CERVICAL COLLARFox Instruments, Inc.1978-06-30160
K780136COLLAR, CERVICAL, SPLITRichard'S Medical Equip., Inc.1978-01-3160
K760644NECKSAVERHealth Saver Corp.1977-02-161540

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