Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Raco Products Co. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932046 | LIFE-TELL T.S.S. | Raco Products Co. | 1994-08-29 | 489 | 0 |
| K923493 | LIFE-TEL T.R.S. | Raco Products Co. | 1992-09-23 | 70 | 0 |
| K922563 | LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) | Raco Products Co. | 1992-07-28 | 57 | 0 |
| K920990 | LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR) | Raco Products Co. | 1992-07-06 | 126 | 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