Product code OLK— Cardiovascular

MightySat -OTC

Classification name: Pulse Oximeter For Over-The-Counter Use
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Total cleared: 2
First cleared: 2024-01-31
Most recent: 2024-11-13

FDA classification definition

“Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring”
— U.S. Food and Drug Administration, device classification record for product code OLK under 21 CFR 870.2700, via openFDA

Market context for product code OLK

FDA has cleared 2 devices under product code OLK, all in 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OLK

Nonin Medical, Inc.1 clearance
Masimo Corporation1 clearance

Recent clearances under product code OLK

K211498 — Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.·2024-11-13
K214115 — MightySat -OTCMasimo Corporation·2024-01-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.