510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OLKClass II

Pulse Oximeter For Over-The-Counter Use

21 CFR 870.2700 / Cardiovascular
FDA source (opens on fda.gov)

OLK is the FDA product code for Pulse Oximeter For Over-The-Counter Use, a class II device type, regulated under 21 CFR 870.2700. FDA's definition for this code reads: "Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OLK
Device name
Pulse Oximeter For Over-The-Counter Use
FDA definition
Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code OLK

By decision year
2 clearances under product code OLK with a decision year between 2024 and 2024, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OLK by decision year
YearClearances
20242

Applicants with the most clearances

Product code OLK
Applicants holding the most 510(k) clearances under product code OLK
ApplicantClearances
Masimo Corporation1
Nonin Medical, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code