Data / Medical devices / United States / HF Acquisition Co. LLC
HF Acquisition Co. LLC: FDA-registered device maker in Mukilteo, WA, United States, 2 510(k) clearances
HF Acquisition Co. LLC is registered with the FDA (registration 3012723641) in Mukilteo, WA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 25, 2004. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012723641
- FEI number
- 3014534
- Address
- 11629 49th Place W, Mukilteo, WA, United States, 98275
- Owner or operator
- HF ACQUISITION CO. LLC (3014534)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 24, 2012
- Registered through
- 2026
- Brand names listed
- BIOlogical12, BIOlogical52, Criti-Kit 200-AI, Criti-Kit CK200 Emergency Response Kit, Inflight Medical Kit Property of American Airlines V2, Mobile ACLS Emergency Medical Kit, Mobile ACLS V2 Emergency Medical Kit, SM Organizer Emergency Medical Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| First Aid Kit With Drug | LRR | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Indicator, Biological Sterilization Process | FRC | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 25, 2004 | K032914 | MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS | FRC | Substantially Equivalent | Raven Biological Laboratories, Inc. | accessdata.fda.gov |
| May 6, 2004 | K041099 | MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP | FRC | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 13, 2026 | 98695 | Class II | Ongoing | 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: The SporeTraq Mail-In | Due to incorrect incubation process being performed on product. | accessdata.fda.gov |
| December 11, 2024 | 96042 | Class II | Ongoing | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580 | Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account. | accessdata.fda.gov |
| April 22, 2022 | 90059 | Class II | Terminated | Surgical Suture Kit | There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity. | accessdata.fda.gov |
| June 5, 2020 | 85898 | Class II | Terminated | 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 emergencies until EMS | A missing component (hand suction pump) in the emergency medical kits. | accessdata.fda.gov |
| June 4, 2020 | 85911 | Class II | Terminated | 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 08/2017 containing vari | Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. | accessdata.fda.gov |
Compare with other makers
Updated June 5, 2026. 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.