Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avery Intl. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
117 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870021 | MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE | Avery Intl. | 1987-02-05 | 34 | 0 |
| K870092 | MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM | Avery Intl. | 1987-02-05 | 27 | 0 |
| K870093 | MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM | Avery Intl. | 1987-02-05 | 27 | 0 |
| K870123 | SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM | Avery Intl. | 1987-02-04 | 23 | 0 |
| K870091 | IV SECUREMENT DEVICE USING PCCE THERMO. FILM | Avery Intl. | 1987-02-04 | 26 | 0 |
| K870020 | IV SECUREMENT DEVICE | Avery Intl. | 1987-02-04 | 33 | 0 |
| K870122 | SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM | Avery Intl. | 1987-02-04 | 23 | 0 |
| K870090 | IV SECUREMENT DEVICE USING HYTREL THERMO. FILM | Avery Intl. | 1987-02-04 | 26 | 0 |
| K870124 | SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM | Avery Intl. | 1987-02-04 | 23 | 0 |
| K862438 | SURGICAL DRAPES AND DRAPE ACCESSORIES | Avery Intl. | 1986-07-16 | 20 | 0 |
| K854464 | IV SECUREMENT DEVICES | Avery Intl. | 1986-03-03 | 117 | 0 |
| K854463 | ADHESIVE TAPE, WOUND CARE, WOUND DRESSING | Avery Intl. | 1986-03-03 | 117 | 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