Instromedix, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Instromedix, Inc.” (first 1977, latest 2001), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 158 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 17 | 17 |
| DTC | Analyzer, Pacemaker Generator Function | 3 | 3 |
| DPS | Electrocardiograph | 2 | 2 |
| KRE | Analyzer, Pacemaker Generator Function, Indirect | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| DXM | Densitometer | 1 | 1 |
Plus 3 more product codes.
Review panels
- Cardiovascular (32)
- Neurology (1)
Most recent Instromedix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010945 | HEARTCARD, MODEL 5258 | DXH | 2001-06-12 | 75 |
| K964408 | POSEIDON CARDIAC MONITORING SYSTEM (PCMS) | DPS | 1997-07-23 | 261 |
| K964036 | CARDIOMAGIC 2000 SOFTWARE | DXH | 1997-07-18 | 283 |
| K955060 | ACCELERATED TRANSMISSION PROTOCOL | DXH | 1996-04-08 | 158 |
| K951096 | LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER | DXH | 1996-01-16 | 315 |
| K945476 | HEARTHWATCH III(TM) | DXH | 1995-11-09 | 366 |
| K950003 | CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS | DXH | 1995-10-31 | 301 |
| K944362 | HEARTCARD CARDIAC EVENT MONITOR | DXH | 1995-09-07 | 365 |
| K943931 | CARRYALL ENHANCEMENTS | DXH | 1995-04-04 | 235 |
| K935586 | PRINCE | DXH | 1994-11-08 | 363 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Instromedix, 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 Instromedix, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances are listed under Instromedix, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Instromedix, Inc.” (first 1977, latest 2001), across 13 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 Instromedix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Instromedix, Inc. is 158 days.
Which FDA product codes appear under Instromedix, Inc.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 17); DTC (Analyzer, Pacemaker Generator Function, 3); DPS (Electrocardiograph, 2).
Next steps
- See all 33 Instromedix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Instromedix, 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.