Intera Corp.: FDA clearances and approvals
Intera Corp. has 6 FDA 510(k) clearances (first 1986, latest 1989), across 2 product codes in 2 review panels. Median 510(k) review time: 45 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | 4 | 4 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
Review panels
Most recent Intera Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891686 | LIB SYSTEM, BABY/ADULT DIAPER | EYQ | 1989-05-31 | 70 |
| K885185 | INTERA SHIELD AND INTERA UNDERGARMENT | EYQ | 1989-02-08 | 56 |
| K883787 | REUSABLE ADULT INCONTINENT DIAPER | EYQ | 1988-11-07 | 61 |
| K883424 | SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB | KKX | 1988-09-06 | 22 |
| K863732 | SURGICAL DRAPE & DRAPE ACCESSORIES | KKX | 1986-10-23 | 30 |
| K862380 | MATTRESS COVER | EYQ | 1986-07-28 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Intera Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Intera Corp. have?
Intera Corp. has 6 FDA 510(k) clearances (first 1986, latest 1989), across 2 product codes in 2 review panels.
How long does FDA take to clear Intera Corp.'s 510(k)s?
The median time from FDA receipt to decision across Intera Corp.'s cleared 510(k)s is 45 days.
What devices does Intera Corp. make?
Its most frequent FDA product codes are EYQ (Garment, Protective, For Incontinence, 4); KKX (Drape, Surgical, Antimicrobial, 2).
Has Intera Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Intera Corp. Related entities may recall under other names.
Next steps
- See all 6 Intera Corp. clearances with predicates and recalls
- Run predicate analysis for product code EYQ, Intera Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.