Arbo Medical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Arbo Medical, Inc.” (first 1989, latest 1995), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 251 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 7 | 7 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 3 | 3 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| JOT | Electrode, Gel, Electrosurgical | 1 | 1 |
Review panels
- Cardiovascular (10)
- General Hospital (3)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Arbo Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940323 | ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM | DSA | 1995-04-12 | 443 |
| K935437 | ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES | DRX | 1995-04-06 | 512 |
| K942905 | DISPOSABLE TEMPERATURE PROBE COVER | FMT | 1995-02-27 | 251 |
| K940302 | ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM | DSA | 1994-11-30 | 310 |
| K940322 | ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE | DSA | 1994-11-28 | 308 |
| K935246 | ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES | DRX | 1994-11-16 | 380 |
| K935429 | ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES | DRX | 1994-11-01 | 356 |
| K935281 | ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES | DRX | 1994-09-06 | 307 |
| K905545 | ULTRASOUND TRANSMISSION GEL | JOT | 1991-03-29 | 108 |
| K902788 | CLEM TM | FIB | 1990-09-12 | 78 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Arbo Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Arbo Medical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Arbo Medical, Inc.” (first 1989, latest 1995), across 6 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 Arbo Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arbo Medical, Inc. is 251 days.
Which FDA product codes appear under Arbo Medical, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 7); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 3); CAH (Filter, Bacterial, Breathing-Circuit, 2).
Next steps
- See all 15 Arbo Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Arbo Medical, 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.