Porter Instrument Co., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Porter Instrument Co., Inc.” (first 1980, latest 2006), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 130 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 |
|---|---|---|---|
| CBN | Apparatus, Gas-Scavenging | 2 | 2 |
| FLE | Sterilizer, Steam | 2 | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 1 | 1 |
Review panels
- Anesthesiology (4)
- General Hospital (2)
Most recent Porter Instrument Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062155 | DIGITAL MXR-D FLOWMETER | BSZ | 2006-11-09 | 104 |
| K981754 | AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 | CBN | 1998-06-16 | 29 |
| K924596 | SES-2012 AUTOMATIC STEAM STERILIZER | FLE | 1994-04-15 | 581 |
| K923781 | MXR-2000 FLOWMETER | CAX | 1993-06-10 | 317 |
| K895638 | STEAM STERILIZER (AUTOCLAVE), DENTAL | FLE | 1990-02-22 | 156 |
| K802067 | CLEAN-AIR POLLUTION REDUCTION SYSTEM | CBN | 1980-09-26 | 30 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-08-26.
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 Porter Instrument Co., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Porter Instrument Co., Inc.” (first 1980, latest 2006), across 4 product codes in 2 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 Porter Instrument Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Porter Instrument Co., Inc. is 130 days.
Which FDA product codes appear under Porter Instrument Co., Inc.?
The most frequent FDA product codes under this applicant name are CBN (Apparatus, Gas-Scavenging, 2); FLE (Sterilizer, Steam, 2); BSZ (Gas-Machine, Anesthesia, 1).
Next steps
- See all 6 Porter Instrument Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBN, Porter Instrument Co., 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.