Data / Medical devices / United States / DRW Medical
DRW Medical: FDA-registered device maker in Aston, PA, United States, 3 510(k) clearances
DRW Medical is registered with the FDA (registration 3015177409) in Aston, PA, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 16, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015177409
- Address
- 2710 Concord Road, Aston, PA, United States, 19014
- Owner or operator
- DRW Medical, LLC (10058504)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 5, 2018
- Registered through
- 2027
- Brand names listed
- Cannuloc, DRW Oxygen Monitor, Exsalta BiDi Catheters, Exsalta Disposable Suction Kits, Exsalta Suction Device, FlowPro Nasal Cannulas, NAPA Extension Cords, NAPA LP-15 Airway Pressure Monitor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer | accessdata.fda.gov |
| Support, Breathing Tube | JAY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2022 | K221676 | Exsalta | BTA | Substantially Equivalent | Drw Medical | accessdata.fda.gov |
| February 9, 2018 | K172284 | NAPA LP-15 Airway Pressure Monitor | CAP | Substantially Equivalent | Drw Medical, LLC | accessdata.fda.gov |
| February 27, 2007 | K063096 | PRECISION OXYGEN MONITOR | CCL | Substantially Equivalent | Precision Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubing, Pressure And Accessories
- All makers of Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- All makers of Support, Breathing Tube
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Tubing, Noninvasive
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
Updated September 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.