Holgrath Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Holgrath Medical Technologies, Inc.” (first 1995, latest 1996), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 245 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 |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 5 | 5 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
Review panels
- Anesthesiology (6)
Most recent Holgrath Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954835 | HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET | CAZ | 1996-01-31 | 103 |
| K946047 | HOLGRATH METAL-HUB, EPIDURAL NEEDLE | BSP | 1995-07-25 | 225 |
| K944908 | HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE | BSP | 1995-06-07 | 245 |
| K944907 | HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE | BSP | 1995-06-07 | 245 |
| K944906 | HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE | BSP | 1995-06-07 | 245 |
| K944905 | HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE | BSP | 1995-06-07 | 245 |
Recalls
openFDA lists no recalls under a recalling firm named Holgrath Medical Technologies, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Holgrath Medical Technologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Holgrath Medical Technologies, Inc.” (first 1995, latest 1996), across 2 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 Holgrath Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Holgrath Medical Technologies, Inc. is 245 days.
Which FDA product codes appear under Holgrath Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 5); CAZ (Anesthesia Conduction Kit, 1).
Next steps
- See all 6 Holgrath Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSP, Holgrath Medical Technologies, 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.