Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NQK · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
116 daysmedian FDA review time
399 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142020 | LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND | Biomonde | 2014-11-05 | 103 | 0 |
| K131221 | LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/ | Biomonde | 2013-08-28 | 120 | 0 |
| K123449 | BIOMONDE LARVAE | Biomonde (A Trading Name of Zoobiotic Limited) | 2013-03-05 | 116 | 0 |
| K102827 | MEDICAL MAGGOTS, LESOC | Monarch Labs, LLC | 2011-11-02 | 399 | 0 |
| K072438 | MEDICAL MAGGOTS, CREATURE COMFORTS | Monarch Labs, LLC | 2007-10-05 | 36 | 1 |
| K033391 | MEDICAL MAGGOTS | Ronald A. Sherman | 2004-01-12 | 81 | 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