Integrated Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Integrated Medical Systems, Inc.” (first 1987, latest 2008), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| LDQ | 1 | 1 | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (3)
- Anesthesiology (1)
Most recent Integrated Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082256 | LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE | MWI | 2008-09-26 | 49 |
| K902682 | STICK-GARD STERILE CAP | LDQ | 1990-09-26 | 99 |
| K895414 | MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM | BZG | 1990-02-12 | 164 |
| K871659 | IMS-2000S STRESS MONITOR | DXG | 1987-05-28 | 30 |
| K870934 | IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM | DXG | 1987-05-06 | 58 |
Recalls
22 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-01-20.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Integrated Display Technology, Ltd. (5 510(k)s)
- Integrated Orbital Implants, Inc. (5 510(k)s)
- Integrated Biomedical Technology, Inc. (3 510(k)s)
- Integrated Endoscopy, Inc. (3 510(k)s)
- Integrated Surgical Systems, Inc. (3 510(k)s)
- Integrated Vascular Systems, Inc. (3 510(k)s)
- Integrated Healing Technologies (2 510(k)s)
- Integrated Medical Systems Int'L., Inc. (2 510(k)s)
- Integrated Biosensing Technologies (1 510(k)s)
- Integrated Biotechnology Corp. (1 510(k)s)
- Integrated Computerized Laboratory Systems, Inc. (1 510(k)s)
- Integrated Dental Systems, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Integrated Medical Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Integrated Medical Systems, Inc.” (first 1987, latest 2008), across 4 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 Integrated Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Integrated Medical Systems, Inc. is 58 days.
Which FDA product codes appear under Integrated Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 2); BZG (Spirometer, Diagnostic, 1); LDQ (device, 1).
Next steps
- See all 5 Integrated Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXG, Integrated Medical Systems, 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.