Hospal Medical Corp.: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Hospal Medical Corp.” (first 1977, latest 1989), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 20 | 20 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 7 | 7 |
| FIE | Needle, Fistula | 4 | 4 |
| FJG | Dialyzer, Parallel Flow | 4 | 4 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 4 | 4 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 4 | 4 |
| FKP | System, Dialysate Delivery, Single Patient | 3 | 3 |
| BZC | Calculator, Pulmonary Function Data | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
Plus 6 more product codes.
Review panels
- Gastroenterology and Urology (50)
- Anesthesiology (3)
- General Hospital (1)
- Pathology (1)
Most recent Hospal Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893742 | FILTRAL TM 20 HEMODIALYZER/FILTER | KDI | 1989-07-24 | 68 |
| K884365 | MULTIFLOW(TM) 60 KIT | KDI | 1988-12-08 | 51 |
| K884326 | FILTRAL TM 8 HEMODIALYZER | KDI | 1988-12-05 | 52 |
| K883307 | CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT | KDI | 1988-10-12 | 69 |
| K872767 | FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER | KDI | 1987-12-29 | 168 |
| K871218 | MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT | FKP | 1987-04-30 | 34 |
| K863961 | HOSPAL BIOSPAL 1800S | KDI | 1986-12-17 | 68 |
| K863592 | DISSCAP 80E, 110E, 140E, 160E | FJI | 1986-09-25 | 10 |
| K861156 | HOSPAL DIALYSATE FOR CAVHD | KPO | 1986-09-23 | 179 |
| K861230 | MONITRAL S | FKP | 1986-04-25 | 24 |
45 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hospal Medical Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Hospal Medical Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hospal (1 510(k)s)
- Hospal Industrie (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hospal Medical Corp.?
FDA lists 55 510(k) clearances under the applicant name “Hospal Medical Corp.” (first 1977, latest 1989), across 16 product codes in 4 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 Hospal Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hospal Medical Corp. is 43 days.
Which FDA product codes appear under Hospal Medical Corp.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 20); FKQ (System, Dialysate Delivery, Central Multiple Patient, 7); FIE (Needle, Fistula, 4).
Next steps
- See all 55 Hospal Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Hospal Medical Corp.'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.