Nestor Engineering Associates, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nestor Engineering Associates, Inc.” (first 1978, latest 1978), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 111 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 |
|---|---|---|---|
| EMF | Knife, Surgical | 2 | 2 |
| KBN | Gag, Mouth | 1 | 1 |
| KCY | Tourniquet, Pneumatic | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Nestor Engineering Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K780991 | PARALLEL BLADE MARKER | EMF | 1978-10-03 | 111 |
| K780990 | STAINLESS STEEL TEMPLATE | — | 1978-10-03 | 111 |
| K780989 | DEVIN-NESTOR SQUARE KNIFE | EMF | 1978-10-03 | 111 |
| K780988 | DEVIN-NESTOR PNEUMATIC TOURNIQUET | KCY | 1978-10-03 | 111 |
| K780992 | MILLARD MOUTH GAG | KBN | 1978-08-17 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Nestor Engineering Associates, Inc..
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.
- Nestor Rehab Products , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nestor Engineering Associates, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Nestor Engineering Associates, Inc.” (first 1978, latest 1978), 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 Nestor Engineering Associates, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nestor Engineering Associates, Inc. is 111 days.
Which FDA product codes appear under Nestor Engineering Associates, Inc.?
The most frequent FDA product codes under this applicant name are EMF (Knife, Surgical, 2); KBN (Gag, Mouth, 1); KCY (Tourniquet, Pneumatic, 1).
Next steps
- See all 5 Nestor Engineering Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EMF, Nestor Engineering Associates, 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, 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.