Swartz Medical Equipment: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Swartz Medical Equipment” (first 1977, latest 1977), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | 4 | 4 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (5)
Most recent Swartz Medical Equipment 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K771502 | ANEROID SPHYGMOMETER | — | 1977-08-30 | 25 |
| K771501 | ANEROID SPHYGMOMETER | DXQ | 1977-08-30 | 25 |
| K771581 | STETHOSCOPE, NURSESCOPE TYPE | DQD | 1977-08-26 | 8 |
| K771506 | STETHOSCOPE | DQD | 1977-08-26 | 21 |
| K771505 | STETHOSCOPE | DQD | 1977-08-26 | 21 |
| K771504 | STETHOSCOPE | DQD | 1977-08-26 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Swartz Medical Equipment.
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 Swartz Medical Equipment?
FDA lists 6 510(k) clearances under the applicant name “Swartz Medical Equipment” (first 1977, latest 1977), across 3 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 Swartz Medical Equipment?
The median time from FDA receipt to decision across 510(k)s cleared under the name Swartz Medical Equipment is 21 days.
Which FDA product codes appear under Swartz Medical Equipment?
The most frequent FDA product codes under this applicant name are DQD (Stethoscope, Electronic, 4); DXQ (Blood Pressure Cuff, 1).
Next steps
- See all 6 Swartz Medical Equipment clearances with predicates and recalls
- Run predicate analysis for product code DQD, Swartz Medical Equipment'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.