Block Medical, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Block Medical, Inc.” (first 1990, latest 1995), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 122 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 4 | 4 |
| FRN | Pump, Infusion | 4 | 4 |
| LDR | Controller, Infusion, Intravascular, Electronic | 1 | 1 |
| MEA | Pump, Infusion, Pca | 1 | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 | 1 |
| MED | Sterilant, Medical Devices | 1 | 1 |
Review panels
- General Hospital (12)
Most recent Block Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944692 | C-SERIES HOMEPUMP | FPA | 1995-05-02 | 221 |
| K940117 | MID-500 | MEB | 1994-06-10 | 151 |
| K934551 | VERIFUSE AMBULATORY PUMP | MEA | 1994-03-17 | 176 |
| K935236 | FLOW CONTROLLING EXTENSION SET | LDR | 1994-02-24 | 115 |
| K932740 | HOMEPUMP NSF | MED | 1993-10-06 | 120 |
| K904663 | AUTO SASH (TM) | FPA | 1992-11-23 | 773 |
| K914924 | CHEMO PRIMING PIN(TM) | FPA | 1992-03-06 | 123 |
| K914855 | MULTIPLE DOSE CONTROLLER | FRN | 1992-01-24 | 88 |
| K914854 | THUMPER | FRN | 1992-01-24 | 88 |
| K910695 | AUTO SASH (TM) | FPA | 1991-03-21 | 30 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Block Medical, Inc..
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 Block Medical, Inc. (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)
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.
- Block Drug Company, Inc. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Block Medical, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Block Medical, Inc.” (first 1990, latest 1995), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Block Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Block Medical, Inc. is 122 days.
Which FDA product codes appear under Block Medical, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 4); FRN (Pump, Infusion, 4); LDR (Controller, Infusion, Intravascular, Electronic, 1).
Next steps
- See all 12 Block Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Block Medical, Inc.'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.