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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930730 | DORMIE NECK SUPPORT SYSTEM | The Western Diagnostics Co. | 1993-07-22 | 161 | 0 |
| K926291 | SCHUL-TEC IMMOBILIZER | Medical Emergency Support Equipment | 1993-03-30 | 106 | 0 |
| K895477 | NOVA PILLOW | Nova Health Systems, Inc. | 1990-01-10 | 121 | 0 |
| K896042 | MEDICAL DISPOSABLE BEDDING | Keystone Veterinary Supplies, Inc. | 1990-01-10 | 86 | 0 |
| K882264 | BATTLE CREEK PILLOW | Battle Creek Equipment Co. | 1988-08-09 | 70 | 0 |
| K850465 | CERVICAL COLLARS & HEAD HALTERS | Abco Dealers, Inc. | 1985-04-25 | 87 | 0 |
| K832990 | STIFNICK IMMOBILIZING COLLAR | Laerdal California, Inc. | 1983-11-07 | 67 | 0 |
| K832001 | HEAD-IMMOBILIZER | Int'L Safety Corp. | 1983-07-12 | 20 | 0 |
| K831582 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | 1983-06-15 | 29 | 0 |
| K830350 | CERVICAL PILLOW | Deip Enterprises, Inc. | 1983-03-09 | 34 | 0 |
| K830348 | VINYL EXTRICATION COLLAR | Deip Enterprises, Inc. | 1983-03-09 | 34 | 0 |
| K830351 | DISPOSABLE EXTRICATION COLLAR | Deip Enterprises, Inc. | 1983-03-09 | 34 | 0 |
| K823667 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823247 | U-WAY QUICKOLLAR | Ems Industries, Inc. | 1982-11-16 | 15 | 0 |
| K823161 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K821837 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | 1982-07-20 | 28 | 0 |
| K820366 | BECSIC COLLAR | Blackstone & Breglio Industries | 1982-03-01 | 20 | 0 |
| K812019 | LOXLEY EMERGENCY CERVICAL COLLAR | Loxley Medical | 1981-10-02 | 81 | 0 |
| K811298 | EXECUTIVE COLLAR | Orthomedics | 1981-05-27 | 16 | 0 |
| K810024 | BONNER BRACE | Bee Ent. | 1981-01-23 | 18 | 0 |
| K803147 | CONPHAR ADJUSTABLE CERVICAL COLLAR | Conphar, Inc. | 1981-01-08 | 27 | 0 |
| K802442 | LOW BACK POSTURE PILLOW | Body Therapeutics, Inc. | 1980-10-31 | 24 | 0 |
| K801628 | RESTRAINT, PROTECTIVE | The Owenby Co. | 1980-08-07 | 23 | 0 |
| K800108 | BASHAW CERVICAL IMMOBILIZER DEVICE | Bashaw Custom Specialties, Inc. | 1980-02-29 | 44 | 0 |
| K780994 | CERVICAL COLLAR | Fox Instruments, Inc. | 1978-06-30 | 16 | 0 |
| K780136 | COLLAR, CERVICAL, SPLIT | Richard'S Medical Equip., Inc. | 1978-01-31 | 6 | 0 |
| K760644 | NECKSAVER | Health Saver Corp. | 1977-02-16 | 154 | 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