Nasiff Assoc., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nasiff Assoc., Inc.” (first 1990, latest 2000), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 182 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| LOS | 1 | 1 |
Review panels
- Cardiovascular (4)
Most recent Nasiff Assoc., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993616 | CARDIO-CARD INTERPRETATION SYSTEM I | LOS | 2000-04-10 | 167 |
| K972795 | CARDIO-CARD MANAGEMENT SYSTEM II | DXN | 1998-02-20 | 207 |
| K960544 | CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM | DRT | 1996-08-07 | 182 |
| K920020 | CARDIO-CARD ECG MANAGEMENT SYSTEM | DPS | 1992-07-09 | 189 |
| K903722 | MICROMED QRS CARD | DPS | 1990-12-05 | 112 |
Recalls
openFDA lists no recalls under a recalling firm named Nasiff Assoc., 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 Nasiff Assoc., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Nasiff Assoc., Inc.” (first 1990, latest 2000), across 4 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 Nasiff Assoc., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nasiff Assoc., Inc. is 182 days.
Which FDA product codes appear under Nasiff Assoc., Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 2); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Next steps
- See all 5 Nasiff Assoc., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Nasiff Assoc., 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.