Dynatech Medical Products: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dynatech Medical Products” (first 1977, latest 1993), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 105 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 |
|---|---|---|---|
| FYC | Gown, Isolation, Surgical | 2 | 2 |
| FRN | Pump, Infusion | 1 | 1 |
| FXW | Shoes, Operating-Room | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
Most recent Dynatech Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923188 | DYNASTY IMPERVIOUS ISOLATION J-SUIT | FYC | 1993-01-29 | 213 |
| K923187 | IMPERVIOUS ISOLATION SHOE COVERS | FXW | 1993-01-29 | 213 |
| K922234 | DYNASTY ISOLATION GOWN | FYC | 1992-08-11 | 90 |
| K893520 | DR. BOO LATEX EXAMINATION GLOVES | LYY | 1989-08-21 | 105 |
| K770730 | PUMP, INFUSION, DYNATECH/HANDLEY | FRN | 1977-07-11 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Dynatech Medical Products.
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 Dynatech Medical Products (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.
- Dynatech Laboratories, Inc. (44 510(k)s)
- Dynatech Corp. (27 510(k)s)
- Dynatech Cryomedical Co. (6 510(k)s)
- Dynatech Research & Development Co. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dynatech Medical Products?
FDA lists 5 510(k) clearances under the applicant name “Dynatech Medical Products” (first 1977, latest 1993), across 4 product codes in 2 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 Dynatech Medical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dynatech Medical Products is 105 days.
Which FDA product codes appear under Dynatech Medical Products?
The most frequent FDA product codes under this applicant name are FYC (Gown, Isolation, Surgical, 2); FRN (Pump, Infusion, 1); FXW (Shoes, Operating-Room, 1).
Next steps
- See all 5 Dynatech Medical Products clearances with predicates and recalls
- Run predicate analysis for product code FYC, Dynatech Medical Products'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.