FDA applicant
Abbott Point of Care, Inc.
FDA records 22 decisions for Abbott Point of Care, Inc. (Princton, NJ) from 2011 to 2026: 22 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…). Since 2016 its 510(k)s took a median of 267 days from receipt to decision, against 258 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 13 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Abbott Point of Care”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Abbott Point of Care, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Abbott Point of Care, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Abbott”
FDA records each applicant name separately; these may or may not be the same firm.