Engineering, Inc.: FDA clearances and approvals
Engineering, Inc. has 5 FDA 510(k) clearances (first 1986, latest 1988), across 5 product codes in 3 review panels. Median 510(k) review time: 56 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
| HHI | System, Abortion, Vacuum | 1 | 1 |
| KDQ | Bottle, Collection, Vacuum | 1 | 1 |
Review panels
Most recent Engineering, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881521 | MODIFIED SERVO SYRINGE | DXT | 1988-05-31 | 53 |
| K862749 | LS9000 SUCTION BIOPSY NEEDLE | GDM | 1986-09-15 | 56 |
| K862476 | LS3000 CANNULA UTERINE SUCTION | HHI | 1986-07-18 | 18 |
| K854359 | LM2000A SURGICAL SUCTION MONITOR | KDQ | 1986-03-03 | 125 |
| K854844 | LS1000 SURGICAL ASPIRATOR II | BTA | 1986-02-12 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Engineering, Inc..
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 Engineering, Inc. have?
Engineering, Inc. has 5 FDA 510(k) clearances (first 1986, latest 1988), across 5 product codes in 3 review panels.
How long does FDA take to clear Engineering, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Engineering, Inc.'s cleared 510(k)s is 56 days.
What devices does Engineering, Inc. make?
Its most frequent FDA product codes are BTA (Pump, Portable, Aspiration (Manual Or Powered), 1); DXT (Injector And Syringe, Angiographic, 1); GDM (Needle, Aspiration And Injection, Reusable, 1).
Has Engineering, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Engineering, Inc. Related entities may recall under other names.
Next steps
- See all 5 Engineering, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTA, Engineering, Inc.'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.