Camino Laboratories, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Camino Laboratories, Inc.” (first 1982, latest 1995), across 8 product codes in 3 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 |
|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | 5 | 5 |
| GWM | Device, Monitoring, Intracranial Pressure | 4 | 4 |
| JXG | Shunt, Central Nervous System And Components | 3 | 3 |
| DSK | Computer, Blood-Pressure | 2 | 2 |
| DYB | Introducer, Catheter | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 1 | 1 |
| HCD | Cannula, Ventricular | 1 | 1 |
Review panels
- Neurology (9)
- Cardiovascular (8)
- General Hospital (1)
Most recent Camino Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932769 | CAMINO VENTRICULAR DRAINAGE SYSTEM | JXG | 1995-03-30 | 660 |
| K930222 | CAMINO VENTRICULAR ACCESS DEVICE | JXG | 1993-04-15 | 90 |
| K930221 | CAMINO VENTRICULAR TRANSDUCER ACCESSORY | GWM | 1993-04-15 | 90 |
| K920088 | CAMINO VENTRICULAR NEEDLE | HCD | 1992-05-01 | 114 |
| K914735 | VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM | GWM | 1992-01-17 | 88 |
| K912833 | CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY | DSK | 1991-09-23 | 89 |
| K893232 | MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM | DSK | 1989-07-14 | 77 |
| K881183 | VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H | GWM | 1988-05-04 | 44 |
| K863969 | CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D | DXO | 1987-05-27 | 225 |
| K861961 | CAMINO CSF DRAINAGE SYSTEM MODEL 040 | JXG | 1986-08-12 | 84 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Camino Laboratories, 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.
- Camino Neurocare, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Camino Laboratories, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Camino Laboratories, Inc.” (first 1982, latest 1995), across 8 product codes in 3 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 Camino Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Camino Laboratories, Inc. is 86 days.
Which FDA product codes appear under Camino Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DXO (Transducer, Pressure, Catheter Tip, 5); GWM (Device, Monitoring, Intracranial Pressure, 4); JXG (Shunt, Central Nervous System And Components, 3).
Next steps
- See all 18 Camino Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXO, Camino Laboratories, 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.