Data / Medical devices / United States / BC Group International, Inc.
BC Group International, Inc.: FDA-registered device maker in Saint Charles, MO, United States, 2 510(k) clearances
BC Group International, Inc. is registered with the FDA (registration 2939012) in Saint Charles, MO, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 21, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2939012
- Address
- 3081 Elm Point Industrial Dr, Saint Charles, MO, United States, 63301
- Owner or operator
- BC Group International, Inc. (10037117)
- Roles
- Manufacturer
- First device listed
- June 20, 2011
- Registered through
- 2026
- Brand names listed
- DA-2006, DA-2006-VL, DA-2006P
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tester, Defibrillator | DRL | 2 | 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 |
|---|---|---|---|---|---|---|
| December 21, 2015 | K153210 | Defibrillator Analyzer Variable Load | DRL | Substantially Equivalent | Bc Group International, Inc. | accessdata.fda.gov |
| February 8, 2011 | K110192 | DEFIBRILLATOR ANALYZER - DA-2006P | DRL | Substantially Equivalent | Bc Group International, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 28, 2015 | 72619 | Class III | Terminated | DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker. | Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms. | accessdata.fda.gov |
Compare with other makers
Updated December 22, 2015. 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.