FDA applicant
Instrumentation Laboratory CO
FDA records 327 decisions for Instrumentation Laboratory CO (Lexington, MA) from 1976 to 2023: 326 510(k) clearances and 1 De Novo grant. Most are in product codes GGP (Test, Qualitative And Quantitative Factor…) and CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…). Since 2016 its 510(k)s took a median of 251 days from receipt to decision, against 249 for FDA’s reviews in the same codes and years. Its devices cite 210 predicates, 154 of them its own earlier devices. 98 recalls are linked to its devices, 2 Class I.
FDA’s records also spell it “Instrumentation Laboratory”, “Instrumentation Laboratory Company”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Instrumentation Laboratory CO’s devices, and how often a recall has named them.
FDA decisions per year
7in 2023
2026 so far, outlined.
Recalls per year
30in 2026
Class I Class II/III not classified
Planning a device like Instrumentation Laboratory CO’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 “Instrumentation”
FDA records each applicant name separately; these may or may not be the same firm.