Hollister, Inc.: FDA clearances and approvals
Hollister, Inc. has 85 FDA 510(k) clearances (first 1977, latest 2013), across 28 product codes in 6 review panels. Median 510(k) review time: 81 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 128 |
| 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 |
|---|---|---|---|
| EXB | Collector, Ostomy | 14 | 14 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 10 | 10 |
| ILO | Pack, Hot Or Cold, Water Circulating | 7 | 7 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 7 | 7 |
| FRO | Dressing, Wound, Drug | 6 | 6 |
| FMQ | Restraint, Protective | 4 | 4 |
| HIR | Perineometer | 4 | 4 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 4 | 4 |
| EXI | Device, Paste-On For Incontinence, Sterile | 2 | 2 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 2 | 2 |
Plus 18 more product codes.
Review panels
- Gastroenterology and Urology (48)
- General and Plastic Surgery (14)
- Physical Medicine (8)
- Obstetrics and Gynecology (7)
- General Hospital (6)
- Orthopedic (1)
Most recent Hollister, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123804 | INSTAFLO BOWEL CATHETER SYSTEM KIT | KNT | 2013-04-17 | 128 |
| K100273 | INSTAFLO BOWEL CATHETER SYSTEM KIT | KNT | 2010-04-22 | 83 |
| K090960 | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, | GBM | 2009-08-20 | 136 |
| K083153 | ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 | KNT | 2009-02-04 | 103 |
| K050483 | EVADRI BLADDER CONTROL SYSTEMS | KPI | 2005-04-12 | 47 |
| K040779 | RESTORE WOUND CLEANSER | KMF | 2004-05-17 | 52 |
| K013612 | INCARE PELVIC FLOOR THERAPY SYSTEM | HIR | 2002-03-19 | 134 |
| K013653 | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE | HIR | 2002-03-05 | 119 |
| K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | KOD | 2002-01-14 | 87 |
| K013345 | INCARE INTERMITTENT CATHETER | KOD | 2002-01-07 | 90 |
75 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hollister, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Hollister, Inc.'s product codes (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances does Hollister, Inc. have?
Hollister, Inc. has 85 FDA 510(k) clearances (first 1977, latest 2013), across 28 product codes in 6 review panels.
How long does FDA take to clear Hollister, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hollister, Inc.'s cleared 510(k)s is 81 days.
What devices does Hollister, Inc. make?
Its most frequent FDA product codes are EXB (Collector, Ostomy, 14); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 10); ILO (Pack, Hot Or Cold, Water Circulating, 7).
Has Hollister, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hollister, Inc. Related entities may recall under other names.
Next steps
- See all 85 Hollister, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EXB, Hollister, Inc.'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.