Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BYL — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
95 daysmedian FDA review time
171 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935126 | NASCOR IGLOO | Nascor Pty. , Ltd. | 1994-10-18 | 355 | 0 |
| K905627 | NASCOR OXYDOME | Nascor Pty. , Ltd. | 1991-06-03 | 171 | 0 |
| K896608 | SPAG PAK | Viratek, Inc. | 1990-04-09 | 139 | 0 |
| K895866 | DIRD INGANT O2 (BIO 2 HOOD) | Bird Products Corp. | 1989-10-27 | 23 | 0 |
| K893713 | NOVA OXYGEN TENT | Nova Health Systems, Inc. | 1989-08-21 | 95 | 0 |
| K893714 | KEYSTONE OXYGEN TENT | Keystone Veterinary Supplies, Inc. | 1989-08-21 | 95 | 0 |
| K882396 | AEROSOL DELIVERY HOOD | Viratek, Inc. | 1988-08-01 | 52 | 0 |
| K851666 | MEDI-COMP NEONATAL OXYGEN HOOD | Medicomp, Inc. | 1985-08-06 | 105 | 0 |
| K852345 | SEA-LONG NECKSEAL & HOOD | Safety Sea Systems, Inc. | 1985-06-20 | 20 | 0 |
| K820640 | HOO2D SEAT-INFANT | Dhd Medical Products Div. Diemolding Corp. | 1982-03-26 | 18 | 0 |
| K802653 | MEDIUM SIZE OXYGEN HOOD #1547 | Ann Arbor Plastics, Inc. | 1980-11-24 | 31 | 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