Arc Medical, Inc.
Scottdale, GA, US
Arc Medical, Inc. appears in FDA device records in Scottdale, GA. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Arc Medical, Inc. between 1993 and 2009. The busiest year on record is 1993, with 1. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1995 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090738 | THERMOFLO HCH, THERMOFLO FILTER | CAH | Substantially Equivalent | |
| K063125 | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) | CAH | Substantially Equivalent | |
| K011212 | FILTERFLO H | CAH | Substantially Equivalent | |
| K982239 | CIRCUIT GUARD | CAH | Substantially Equivalent | |
| K924997 | EDD | BTR | Substantially Equivalent | |
| K924627 | XTEND CIRCUITS (TM) | CAI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1596-2015 | ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit. | Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain