# K254287: Medline Reusable Blood Pressure Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Jun 22, 2026 after 173 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010686 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233276: Reusable Blood Pressure Cuff, Suzhou Minhua Medical Apparatus Supplies Co., Ltd. (2023) Summary page 5.

## Indications for use
The Medline Reusable Blood Pressure Cuffs are intended to be used by medical professionals in conjunction with non-invasive blood pressure measurement systems for the determination of a person's blood pressure. The cuffs are non-sterile, multi-patient use and are tested for up to 10,000 inflation cycles and 100 cleaning/Disinfection cycles. Medline Blood Pressure cuff adapters and connectors are intended to be used by medical professionals in conjunction with non-invasive blood pressure systems and blood pressure cuffs for determination of a person’s blood pressure. The Blood Pressure Cuff adapter is for single monitor use only. The Blood Pressure Cuff adapter has been validated for use for up to 10,000 cycles or up to 10,000 connections/disconnections.

Source page: https://510kreport.com/device/K254287
Methodology: https://510kreport.com/methodology