Neotech Products, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Neotech Products, Inc.” (first 1988, latest 2002), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 117 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Review panels
Most recent Neotech Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011564 | NEOLEAD | DRX | 2002-01-03 | 227 |
| K931727 | URINARY DRAINAGE BAG CADDY | FAQ | 1993-07-23 | 142 |
| K921024 | URO-TOTE LEG BAG | KNX | 1992-09-02 | 183 |
| K890425 | NEOTECH MUCUS TRAP W/CATHETER | BSY | 1989-04-19 | 83 |
| K882203 | NEOTECH UNIVERSAL ADAPTER | BZA | 1988-06-17 | 23 |
| K880487 | NEOTECH MECONIUM ASPIRATOR (STERILE) | BTR | 1988-05-06 | 92 |
Recalls
openFDA lists no recalls under a recalling firm named Neotech Products, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neotech Products, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Neotech Products, Inc.” (first 1988, latest 2002), across 6 product codes in 3 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 Neotech Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neotech Products, Inc. is 117 days.
Which FDA product codes appear under Neotech Products, Inc.?
The most frequent FDA product codes under this applicant name are BSY (Catheters, Suction, Tracheobronchial, 1); BTR (Tube, Tracheal (W/Wo Connector), 1); BZA (Connector, Airway (Extension), 1).
Next steps
- See all 6 Neotech Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSY, Neotech Products, 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.