Stackhouse Assoc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Stackhouse Assoc.” (first 1979, latest 1991), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| JDY | Evacuator, Vapor, Cement Monomer | 1 | 1 |
Review panels
- General Hospital (4)
- Orthopedic (1)
Most recent Stackhouse Assoc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912651 | AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM | FYD | 1991-07-08 | 21 |
| K910515 | FREEDOM MARK III SURGICAL HELMET SYSTEM | FYA | 1991-05-06 | 90 |
| K874512 | MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM | FYD | 1988-01-27 | 86 |
| K872935 | ANTI-INFECTION SHIELD | FXX | 1987-11-09 | 105 |
| K790877 | BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO | JDY | 1979-05-23 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Stackhouse Assoc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Stackhouse, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stackhouse Assoc.?
FDA lists 5 510(k) clearances under the applicant name “Stackhouse Assoc.” (first 1979, latest 1991), 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 Stackhouse Assoc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stackhouse Assoc. is 86 days.
Which FDA product codes appear under Stackhouse Assoc.?
The most frequent FDA product codes under this applicant name are FYD (Apparatus, Exhaust, Surgical, 2); FXX (Mask, Surgical, 1); FYA (Gown, Surgical, 1).
Next steps
- See all 5 Stackhouse Assoc. clearances with predicates and recalls
- Run predicate analysis for product code FYD, Stackhouse Assoc.'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.