Arbor Technologies, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Arbor Technologies, Inc.” (first 1986, latest 1997), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 217 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 |
|---|---|---|---|
| BSN | Filter, Conduction, Anesthetic | 2 | 2 |
| FPB | Filter, Infusion Line | 2 | 2 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | 2 |
| CAK | Microfilter, Blood Transfusion | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| JDY | Evacuator, Vapor, Cement Monomer | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Arbor Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960928 | SYRINGEFILTER | BSN | 1997-04-04 | 393 |
| K964283 | AUTOPRIME | FPB | 1997-01-22 | 86 |
| K922777 | PRESSURE TUBING AND ACCESSORIES | HIF | 1994-03-22 | 651 |
| K902666 | ANESTHESIA CONDUCTION FILTER | BSN | 1991-04-23 | 309 |
| K895859 | CONTAIN(TM) | GCX | 1991-02-07 | 492 |
| K902167 | CONTAIN(TM) LASER PLUME FILTER | JDY | 1991-01-04 | 234 |
| K890844 | MICROSEPT 60/20 | CAK | 1989-06-07 | 106 |
| K874505 | CONTAIN(TM) | GCX | 1988-05-20 | 200 |
| K864113 | CLYDE (TM) FILTRATION SYSTEM | FPB | 1987-02-04 | 106 |
| K863162 | VACU-GUARD | — | 1986-08-29 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Arbor Technologies, 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.
- Arbor Endovascular, LLC (5 510(k)s)
- Arbor Medical Innovations, LLC (1 510(k)s)
- Arbor Research Corp. (1 510(k)s)
- Arbor Vita Corportation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Arbor Technologies, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Arbor Technologies, Inc.” (first 1986, latest 1997), across 7 product codes in 4 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 Arbor Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arbor Technologies, Inc. is 217 days.
Which FDA product codes appear under Arbor Technologies, Inc.?
The most frequent FDA product codes under this applicant name are BSN (Filter, Conduction, Anesthetic, 2); FPB (Filter, Infusion Line, 2); GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 2).
Next steps
- See all 10 Arbor Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSN, Arbor Technologies, 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.