Helix Medical, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Helix Medical, Inc.” (first 1989, latest 2002), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 107 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 |
|---|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | 10 | 10 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
| GBW | Catheter, Peritoneal | 1 | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 | 1 |
Review panels
- Ear, Nose and Throat (10)
- Anesthesiology (2)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Helix Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | FDF | 2002-12-26 | 87 |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | EWL | 1999-06-25 | 49 |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | EWL | 1994-12-09 | 39 |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | EWL | 1994-12-02 | 32 |
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | EWL | 1994-04-15 | 347 |
| K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | EWL | 1993-12-15 | 225 |
| K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | EWL | 1993-05-17 | 126 |
| K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | EWL | 1992-09-10 | 246 |
| K915786 | BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. | BYD | 1992-06-30 | 189 |
| K904729 | BLOM-SINGER SHOWER GUARD | EWL | 1991-02-28 | 134 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Helix 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.
- Helix Diagnostics, Inc. (15 510(k)s)
- Helix Medical, LLC (4 510(k)s)
- Helix Opco, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Helix Medical, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Helix Medical, Inc.” (first 1989, latest 2002), across 5 product codes in 4 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 Helix Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Helix Medical, Inc. is 107 days.
Which FDA product codes appear under Helix Medical, Inc.?
The most frequent FDA product codes under this applicant name are EWL (Prosthesis, Laryngeal (Taub), 10); BYD (Condenser, Heat And Moisture (Artificial Nose), 1); FDF (Colonoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 14 Helix Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EWL, Helix 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.