Dryden Corp.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Dryden Corp.” (first 1976, latest 1988), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 4 | 4 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 3 | 3 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 | 3 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BTC | Bag, Reservoir | 1 | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BTQ | Airway, Nasopharyngeal | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent Dryden Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880923 | PATIENT VENTILATOR ISOLATOR | CBK | 1988-09-06 | 186 |
| K880769 | BREATHING CIRCUIT W/HEATED WIRE | BZE | 1988-08-24 | 177 |
| K882285 | NONREBREATHING CIRCUIT | BTM | 1988-08-16 | 76 |
| K873928 | UNIVERSAL TOURNIQUET | GAX | 1987-10-23 | 28 |
| K873927 | REUSEABLE BREATHING TUBES | BZO | 1987-10-20 | 25 |
| K870859 | BAG-TAIL BLEED VALVE | CAI | 1987-08-03 | 153 |
| K871386 | BREATHING CIRCUIT | CAI | 1987-05-29 | 52 |
| K870858 | BADGWELL SAMPLING CATHETER | CCK | 1987-05-14 | 72 |
| K861540 | DISPOSABLE BERMAN AND GUEDEL AIRWAYS | CAE | 1986-05-02 | 8 |
| K850644 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI | BTQ | 1985-03-21 | 30 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dryden Corp..
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 Dryden Corp.?
FDA lists 21 510(k) clearances under the applicant name “Dryden Corp.” (first 1976, latest 1988), across 14 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 Dryden Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dryden Corp. is 29 days.
Which FDA product codes appear under Dryden Corp.?
The most frequent FDA product codes under this applicant name are CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 4); BZO (Set, Tubing And Support, Ventilator (W Harness), 3); CAH (Filter, Bacterial, Breathing-Circuit, 3).
Next steps
- See all 21 Dryden Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAI, Dryden Corp.'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.