Hood Laboratories: FDA clearances and approvals
Hood Laboratories has 19 FDA 510(k) clearances (first 1985, latest 1993), across 12 product codes in 4 review panels. Median 510(k) review time: 84 days.
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 |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 4 | 4 |
| ESW | Prosthesis, Esophageal | 2 | 2 |
| EWL | Prosthesis, Laryngeal (Taub) | 2 | 2 |
| FWN | Prosthesis, Larynx (Stents And Keels) | 2 | 2 |
| KYF | Implant, Eye Valve | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BXQ | Rhinoanemometer (Measurement Of Nasal Decongestion) | 1 | 1 |
| EPP | Splint, Nasal | 1 | 1 |
| ESZ | Tube, Shunt, Endolymphatic | 1 | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Hood Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921452 | ACOUSTIC RHINOMETER | BXQ | 1993-07-08 | 469 |
| K920994 | HOOD NASAL SEPTAL BUTTON | LFB | 1992-05-15 | 74 |
| K905703 | KRUPIN EYE VALVE WITH DISK | KYF | 1991-03-15 | 85 |
| K904821 | ELIACHAR MODIFIED ESOPHAGEAL STENT | ESW | 1991-01-14 | 82 |
| K897049 | GIBSON ENDOLYMPHATIC SHUNT | ESZ | 1990-03-16 | 88 |
| K897059 | HOOD SPEAKING VALVE | JOH | 1990-03-12 | 84 |
| K893866 | HOOD PEDIATRIC TRACHEOSTOMY TUBE | BTO | 1989-08-07 | 73 |
| K884810 | SILICONE LARYNGEAL STENT | FWN | 1989-05-10 | 174 |
| K890599 | HOOD NASAL SPLINT | EPP | 1989-03-17 | 39 |
| K885125 | KRUPIN EYE VALVE W/SCLERAL BUCKLE | KYF | 1989-01-24 | 43 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hood Laboratories.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hood Laboratories have?
Hood Laboratories has 19 FDA 510(k) clearances (first 1985, latest 1993), across 12 product codes in 4 review panels.
How long does FDA take to clear Hood Laboratories's 510(k)s?
The median time from FDA receipt to decision across Hood Laboratories's cleared 510(k)s is 84 days.
What devices does Hood Laboratories make?
Its most frequent FDA product codes are BTO (Tube, Tracheostomy (W/Wo Connector), 4); ESW (Prosthesis, Esophageal, 2); EWL (Prosthesis, Laryngeal (Taub), 2).
Has Hood Laboratories had device recalls?
openFDA lists no recalls under a recalling firm name matching Hood Laboratories. Related entities may recall under other names.
Next steps
- See all 19 Hood Laboratories clearances with predicates and recalls
- Run predicate analysis for product code BTO, Hood Laboratories's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.