Ideal Medical, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Ideal Medical, Inc.” (first 1981, latest 1994), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 136 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| LQR | Dislodger, Stone, Biliary | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| GCS | Endoscope, Battery-Powered And Accessories | 1 | 1 |
Plus 3 more product codes.
Review panels
- General and Plastic Surgery (7)
- Cardiovascular (3)
- Gastroenterology and Urology (3)
- General Hospital (2)
- Anesthesiology (1)
Most recent Ideal Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944067 | PEANUT WAND, MODIFICATION | GCS | 1994-12-08 | 135 |
| K931115 | HATCHER STONE-EMBOLIS EXTRACTOR | LQR | 1993-08-20 | 169 |
| K926335 | IDEAS PEANUT WAND | GCJ | 1993-06-24 | 190 |
| K922161 | GRICE SOFT TISSUE BIOPSY KIT | KNW | 1992-10-13 | 159 |
| K921922 | GRICE LAPAROSCOPIC SUTURING NEEDLE | GCJ | 1992-07-08 | 76 |
| K915175 | REDDICK RETRACTOR | GAD | 1992-04-29 | 166 |
| K914880 | DUAL BALLOON EMBOLECTOMY CATHETER | DXE | 1992-03-16 | 138 |
| K913602 | IDEAS' PORT | FMF | 1992-01-02 | 142 |
| K914913 | GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST | GDJ | 1991-12-31 | 60 |
| K912540 | CONTOUR-PORT | LJT | 1991-08-23 | 74 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ideal Medical, 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.
- Ideal Quality Sdn., Bhd. (4 510(k)s)
- Ideal Life, Inc. (3 510(k)s)
- Ideal Plastic Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ideal Medical, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Ideal Medical, Inc.” (first 1981, latest 1994), across 13 product codes in 5 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 Ideal Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ideal Medical, Inc. is 136 days.
Which FDA product codes appear under Ideal Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXE (Catheter, Embolectomy, 2); GCJ (Laparoscope, General & Plastic Surgery, 2); LQR (Dislodger, Stone, Biliary, 2).
Next steps
- See all 16 Ideal Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXE, Ideal Medical, 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.