Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Level 1 Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
203 daysmedian FDA review time
680 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942844 | LEVEL 1 BLOOD STREAM RECOVERY SYSTEM | Level 1 Technologies, Inc. | 1996-04-26 | 680 | 0 |
| K942271 | LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE | Level 1 Technologies, Inc. | 1995-07-12 | 428 | 0 |
| K936223 | PRESSURE IRRIGATING SYSTEM | Level 1 Technologies, Inc. | 1994-05-12 | 134 | 0 |
| K911383 | HOTLINE FLUID WARMER | Level 1 Technologies, Inc. | 1991-10-17 | 203 | 11 |
| K873435 | LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET | Level 1 Technologies, Inc. | 1987-10-05 | 40 | 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