Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CCX — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
32 daysmedian FDA review time
146 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943837 | CHIN UP | Edward Carden | 1994-10-14 | 70 | 0 |
| K932305 | VILA-COOKE(TM) ANESTHESIA PILLOW | Sharn, Inc. | 1993-10-05 | 146 | 0 |
| K934235 | SNIFF POSITION PILLOW | American Medical Development, Inc. | 1993-10-01 | 32 | 0 |
| K861915 | SURGICAL HEAD SUPPORT | Treace Medical, Inc. | 1986-05-30 | 11 | 0 |
| K833022 | AIR UTERINE DISPLACER-AUD 120 | Scientific Sales Intl., Inc. | 1983-10-14 | 38 | 0 |
| K821838 | VARI-SUPPORT LOW BACK POSTURE PILLOW | Body Therapeutics, Inc. | 1982-07-20 | 28 | 0 |
| K810035 | PRENATAL SUPPORT PILLOW | Supportech, Inc. | 1981-01-23 | 14 | 0 |
| K801330 | ANSPACH LEG SUPPORT | The Anspach Effort, Inc. | 1980-06-26 | 23 | 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