Innovative Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Innovative Medical Systems, Inc.” (first 1978, latest 1997), plus 1 PMA decision, across 13 product codes in 7 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| IEO | Processor, Tissue, Automated | 5 | 5 |
| KPA | Slide Stainer, Automated | 4 | 4 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 | 3 |
| HQC | Unit, Phacofragmentation | 2 | 2 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| GKH | Apparatus, Automated Blood Cell Diluting | 1 | 1 |
| GKR | System, Hemoglobin, Automated | 1 | 1 |
| GLE | Mixer, Blood Tube | 1 | 1 |
Plus 3 more product codes.
Review panels
- Pathology (9)
- Clinical Chemistry (5)
- Hematology (2)
- General Hospital (2)
- Ophthalmic (2)
- Anesthesiology (1)
- Dental (1)
Most recent Innovative Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973035 | VIOLA II DENTAL CAMERA SYSTEM | EIA | 1997-09-24 | 41 |
| K951469 | BAZOOKA SYSTEM | FNM | 1995-06-28 | 90 |
| K933184 | POSITIVE AIRWAY PRESSURE SYSTEM | BZD | 1994-11-28 | 516 |
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | IEO | 1992-12-29 | 110 |
| K922081 | LABOTECH AUTOMATED MICROTITER ANALYZER | JJQ | 1992-09-02 | 120 |
| K921005 | AUTOLOADER | JQW | 1992-04-29 | 57 |
| K915457 | PHACO 20/20 SYSTEM I | HQC | 1992-02-24 | 81 |
| K915456 | PHACO 3000 LINEAR | HQC | 1992-02-12 | 69 |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | IEO | 1988-09-02 | 10 |
| K880745 | LX-100 SLIDE STAINER | KPA | 1988-04-27 | 63 |
12 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P980015 | PMA | SHARPX | 1998-08-06 |
Recalls
openFDA lists no recalls under a recalling firm named Innovative Medical Systems, 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.
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.
- Innovative Health, LLC (50 510(k)s)
- Innovative Technologies , Ltd. (14 510(k)s)
- Innovative Surgical Products, Inc. (12 510(k)s)
- Innovative Diagnostic Systems, Inc. (11 510(k)s)
- Innovative Gloves Co;, Ltd. (9 510(k)s)
- Innovative Surgical Designs, Inc. (9 510(k)s)
- Innovative Bioceramix, Inc. (8 510(k)s)
- Innovative Surgical, Inc. (7 510(k)s)
- Innovative Medical Technologies, Inc. (6 510(k)s)
- Innovative Spinal Technologies, Inc. (4 510(k)s)
- Innovative Therapies, Inc. (4 510(k)s)
- Innovative Trauma Care, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innovative Medical Systems, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Innovative Medical Systems, Inc.” (first 1978, latest 1997), plus 1 PMA decision, across 13 product codes in 7 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 Innovative Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innovative Medical Systems, Inc. is 40 days.
Which FDA product codes appear under Innovative Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are IEO (Processor, Tissue, Automated, 5); KPA (Slide Stainer, Automated, 4); JQW (Station, Pipetting And Diluting, For Clinical Use, 3).
Next steps
- See all 22 Innovative Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IEO, Innovative 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.