Holter-Hausner Intl.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Holter-Hausner Intl.” (first 1978, latest 1988), across 12 product codes in 6 review panels. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 21 | 21 |
| HXA | Prosthesis, Tendon, Passive | 6 | 6 |
| GYK | Instrument, Shunt System Implantation | 5 | 5 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| GXR | Cover, Burr Hole | 1 | 1 |
| HAO | Instrument, Surgical, Non-Powered | 1 | 1 |
| HXR | Spatula, Orthopedic | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
| KOB | Catheter, Suprapubic (And Accessories) | 1 | 1 |
| LFJ | Catheter, Subclavian | 1 | 1 |
Plus 2 more product codes.
Review panels
- Neurology (28)
- Orthopedic (6)
- Gastroenterology and Urology (3)
- Anesthesiology (1)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Holter-Hausner Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K875287 | H-H FLUSHING RESERVOIR | JXG | 1988-07-14 | 198 |
| K874508 | H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG | JXG | 1988-01-19 | 78 |
| K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC | HXA | 1987-09-28 | 104 |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | HXA | 1987-09-28 | 104 |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | HXA | 1987-09-28 | 104 |
| K871351 | H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP | BZD | 1987-05-14 | 38 |
| K870660 | H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS | JXG | 1987-05-01 | 71 |
| K865075 | H-H SUBGALEAL TROCAR | GYK | 1987-01-13 | 15 |
| K853437 | H-H HUNTER TENDON ROD | — | 1985-10-16 | 62 |
| K853436 | H-H HUNTER PASSIVE TENDON IMPLANT | HXR | 1985-10-16 | 62 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Holter-Hausner Intl..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Holter-Hausner Intl.?
FDA lists 42 510(k) clearances under the applicant name “Holter-Hausner Intl.” (first 1978, latest 1988), across 12 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Holter-Hausner Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Holter-Hausner Intl. is 28 days.
Which FDA product codes appear under Holter-Hausner Intl.?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 21); HXA (Prosthesis, Tendon, Passive, 6); GYK (Instrument, Shunt System Implantation, 5).
Next steps
- See all 42 Holter-Hausner Intl. clearances with predicates and recalls
- Run predicate analysis for product code JXG, Holter-Hausner Intl.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.