Neomed, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Neomed, Inc.” (first 1978, latest 2019), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 65 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 | 2 | 68 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 108 |
| 2016 | 1 | 65 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 131 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neomed, Inc. took a median 131 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PNR | Enteral Syringes With Enteral Specific Connectors | 4 | 4 |
| FMF | Syringe, Piston | 2 | 2 |
| FOS | Catheter, Umbilical Artery | 2 | 2 |
| FPD | Tube, Feeding | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| EZD | Catheter, Straight | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HAM | Apparatus, Electrosurgical | 1 | 1 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 1 | 1 |
Review panels
- Gastroenterology and Urology (9)
- General Hospital (4)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Obstetrics and Gynecology (1)
Most recent Neomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) | PNR | 2019-04-30 | 131 |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) | PNR | 2016-06-17 | 65 |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps | PNR | 2015-12-17 | 78 |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector | PNR | 2015-04-09 | 139 |
| K122373 | NEOMED ORAL/ENTERAL SYRINGE | FMF | 2012-09-20 | 45 |
| K120182 | NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES | KNT | 2012-04-19 | 90 |
| K100288 | NEOMED ENTERAL ONLY EXTENSION SET | KNT | 2010-08-03 | 183 |
| K092908 | NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO | FMF | 2010-03-10 | 169 |
| K082238 | NEOMED POLYURETHANE FEEDING TUBE | FPD | 2008-10-01 | 55 |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | FOS | 2008-07-21 | 52 |
7 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-10-24.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neomed, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Neomed, Inc.” (first 1978, latest 2019), across 10 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 Neomed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neomed, Inc. is 65 days.
Which FDA product codes appear under Neomed, Inc.?
The most frequent FDA product codes under this applicant name are PNR (Enteral Syringes With Enteral Specific Connectors, 4); FMF (Syringe, Piston, 2); FOS (Catheter, Umbilical Artery, 2).
Next steps
- See all 17 Neomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PNR, Neomed, 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.