Facet Technologies, LLC.
Atlanta, GA, US
Facet Technologies, LLC. appears in FDA device records in Atlanta, GA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Facet Technologies, LLC. between 2014 and 2024. The busiest year on record is 2014, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 3 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232912 | Facet Aurora Reusable Lancet Base | QRL | Substantially Equivalent | |
| K223370 | NeatNick Heel Safety Lancet | FMK | Substantially Equivalent | |
| K223099 | Facet Manatee Reusable Lancing Base | QRL | Substantially Equivalent | |
| K222539 | Facet Blood Lancets | QRL | Substantially Equivalent | |
| K221433 | Facet 28G Universal Lancet | QRK | Substantially Equivalent | |
| K141749 | CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT | FMI | Substantially Equivalent | |
| K140568 | CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT | FMI | Substantially Equivalent | |
| K133100 | CAREFINE PEN NEEDLE | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011617315 | 3011617315 | Facet Technologies, LLC. | 3900 North Commerce Drive, Atlanta, GA 30344 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0174-2009 | Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431. Lancing Device intended to be used by diabetes patients that require a drop of capillary blood for testing. | The Alternate Site Cap was not included in the package as indicated on the labeling. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain