Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intera Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
70 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891686 | LIB SYSTEM, BABY/ADULT DIAPER | Intera Corp. | 1989-05-31 | 70 | 0 |
| K885185 | INTERA SHIELD AND INTERA UNDERGARMENT | Intera Corp. | 1989-02-08 | 56 | 0 |
| K883787 | REUSABLE ADULT INCONTINENT DIAPER | Intera Corp. | 1988-11-07 | 61 | 1 |
| K883424 | SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB | Intera Corp. | 1988-09-06 | 22 | 0 |
| K863732 | SURGICAL DRAPE & DRAPE ACCESSORIES | Intera Corp. | 1986-10-23 | 30 | 0 |
| K862380 | MATTRESS COVER | Intera Corp. | 1986-07-28 | 34 | 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