Interspec, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Interspec, Inc.” (first 1982, latest 1994), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 95 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 6 | 6 |
| JOP | Transducer, Ultrasonic | 3 | 3 |
| DXK | Echocardiograph | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
Review panels
- Radiology (8)
- Cardiovascular (7)
- Neurology (2)
Most recent Interspec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940671 | INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER | ITX | 1994-11-22 | 279 |
| K924231 | INTERSPEC APOGEE CLA | IYO | 1993-06-14 | 297 |
| K915696 | INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE | ITX | 1992-11-24 | 337 |
| K920678 | ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER | ITX | 1992-04-02 | 48 |
| K911073 | PROBE REFILL KIT | ITX | 1991-06-06 | 87 |
| K910049 | INTERSPEC APOGEE, MODIFICATION | DPW | 1991-04-29 | 112 |
| K903839 | INTERSPEC APOGEE | DXK | 1990-11-16 | 87 |
| K900155 | INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER | ITX | 1990-10-05 | 266 |
| K892944 | INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 | JOP | 1989-07-19 | 89 |
| K890173 | INTERSPEC APOGEE | IYO | 1989-04-14 | 87 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Interspec, 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 Interspec, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Interspec, Inc.” (first 1982, latest 1994), across 8 product codes in 3 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 Interspec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Interspec, Inc. is 95 days.
Which FDA product codes appear under Interspec, Inc.?
The most frequent FDA product codes under this applicant name are ITX (Transducer, Ultrasonic, Diagnostic, 6); JOP (Transducer, Ultrasonic, 3); DXK (Echocardiograph, 2).
Next steps
- See all 17 Interspec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ITX, Interspec, 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.