Medline Digital Rectal Thermometer Sheath

by Medline Industries, Inc. 510(k)

Active United States

510(k) K183431

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK183431	Date14 Jun 2019Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K183431
FDA Product Code: FLL

Device Class: Class II
Regulation: 21 CFR Part 880.2910
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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