Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Guardian Angel Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
234 daysmedian FDA review time
347 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030547 | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE | Guardian Angel Products, Inc. | 2003-07-11 | 141 | 0 |
| K923840 | NEEDLE-GRABBER | Guardian Angel Products, Inc. | 1993-07-13 | 347 | 0 |
| K923835 | THE ELEVENTH FINGER | Guardian Angel Products, Inc. | 1993-07-09 | 343 | 0 |
| K910687 | GUARDIAN GEL, SURGEON'S GLOVING CREAM | Guardian Angel Products, Inc. | 1991-10-11 | 234 | 0 |
| K896985 | ZAP-GUARD | Guardian Angel Products, Inc. | 1990-07-31 | 230 | 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