Advance Medical Designs, Inc.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Advance Medical Designs, Inc.” (first 1985, latest 2023), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 72 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 | 1 | 358 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 236 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Advance Medical Designs, Inc. took a median 297 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 167 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 5 | 5 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 4 | 4 |
| KPE | Container, I.V. | 3 | 3 |
| DRC | Trocar | 2 | 2 |
| FMF | Syringe, Piston | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| EKJ | Burnisher, Operative | 1 | 1 |
Plus 9 more product codes.
Review panels
- General Hospital (15)
- Cardiovascular (7)
- Radiology (5)
- General and Plastic Surgery (3)
- Anesthesiology (1)
- Dental (1)
Most recent Advance Medical Designs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223689 | Disposable Needle Guides and Grids | ITX | 2023-08-02 | 236 |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | MUI | 2017-10-25 | 358 |
| K053495 | EQUIPMENT SLUSH DRAPE | KKX | 2006-03-16 | 91 |
| K011265 | ULTRASOUND TRANSDUCER COVER | ITX | 2001-10-30 | 188 |
| K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH | KKX | 2001-09-18 | 68 |
| K011422 | SURGICAL DRAPES | KKX | 2001-07-10 | 62 |
| K003670 | PATIENT DRAPE, SURGICAL | KKX | 2001-01-26 | 59 |
| K925115 | AMD DENTIST AND HYGIENIST KITS | EKJ | 1994-07-05 | 634 |
| K911884 | ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES | DTL | 1994-07-05 | 1163 |
| K915301 | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK | DTL | 1992-12-11 | 386 |
22 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 2 recall events; 6 initiated in the last five years. Most recent: 2023-07-07.
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.
- Advance Medical Device, Inc. (5 510(k)s)
- Advance Suture, Inc. (5 510(k)s)
- Advance Rubber, Inc. (3 510(k)s)
- Advance Corp. (1 510(k)s)
- Advance Tech Intl. (1 510(k)s)
- Advance Sentry Corporation (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advance Medical Designs, Inc.?
FDA lists 32 510(k) clearances under the applicant name “Advance Medical Designs, Inc.” (first 1985, latest 2023), across 19 product codes in 6 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 Advance Medical Designs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advance Medical Designs, Inc. is 72 days.
Which FDA product codes appear under Advance Medical Designs, Inc.?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 5); DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 4); KPE (Container, I.V., 3).
Next steps
- See all 32 Advance Medical Designs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Advance Medical Designs, 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.