Spectramed, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Spectramed, Inc.” (first 1987, latest 1990), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| KXO | Monitor, Pressure, Intrauterine | 4 | 4 |
| DQF | Actuator, Syringe, Injector Type | 1 | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| KRB | Probe, Thermodilution | 1 | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
Review panels
Most recent Spectramed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | KXO | 1990-01-19 | 87 |
| K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | KRB | 1989-11-06 | 199 |
| K895323 | MODEL DT-BAL, BALANCE SAVER | KXO | 1989-10-24 | 56 |
| K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | KXO | 1989-08-15 | 32 |
| K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | KXO | 1989-02-01 | 274 |
| K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | DSK | 1989-01-25 | 36 |
| K881825 | MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH | DYB | 1988-09-28 | 152 |
| K875337 | HEPARIN COATED LUMINAL PACING CATHETER | DQO | 1988-05-25 | 147 |
| K880740 | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE | DQF | 1988-03-22 | 27 |
| K873168 | SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS | DRS | 1988-01-12 | 154 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spectramed, 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 Spectramed, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Spectramed, Inc.” (first 1987, latest 1990), across 10 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 Spectramed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spectramed, Inc. is 112 days.
Which FDA product codes appear under Spectramed, Inc.?
The most frequent FDA product codes under this applicant name are KXO (Monitor, Pressure, Intrauterine, 4); DQF (Actuator, Syringe, Injector Type, 1); DQO (Catheter, Intravascular, Diagnostic, 1).
Next steps
- See all 13 Spectramed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KXO, Spectramed, 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.