Company
HF Acquisition Co., LLC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
8recalls (2 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | HF Acquisition Co LLC Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS
Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS
Model/Catalog Number: 1023770
Software Version: N/A
Product Description: T Open, Classified |
FRC | K032914 K050591 |
| Jun 5, 2026 | HF Acquisition Co LLC Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS
Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS
Model/Catalog Number: 1023780
Software Version: N/A
Product Description: T Open, Classified |
FRC | K032914 K050591 |
| Feb 11, 2025 | HF Acquisition Co LLC Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600.
Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580 Open, Classified |
FRC | K023716 K041099 +1 |
| Aug 12, 2020 | HF Acquisition Co., LLC STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300 Terminated |
LRR | None listed |
| Aug 12, 2020 | HF Acquisition Co., LLC STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300 Terminated |
LRR | None listed |
| Aug 12, 2020 | HF Acquisition Co., LLC STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300 Terminated |
LRR | None listed |
| Aug 12, 2020 | HF Acquisition Co., LLC HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/ Terminated |
LRR | None listed |
| Jun 5, 2020 | HF Acquisition Co. LLC STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical em Terminated |
LRR | None listed |