510(k) K994044

CLEEN-ABLE by Vital Signs, Inc. — Product Code DXQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 25, 2000
Date Received: November 29, 1999
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Blood Pressure Cuff
Device Class: Class II
Regulation Number: 870.1120
Review Panel: CV
Submission Type

A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

Other clearances by Vital Signs, Inc.

K112902 — ENFLOW IV FLUID WARMER (March 14, 2012)
K041309 — IMASK TM (June 30, 2004)
K030985 — BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (October 15, 2003)
K022402 — DISPOSABLE PRESSURE MANOMETER (August 22, 2002)
K021315 — SURE-LOK (August 21, 2002)
K002454 — BREAS HA50 HUMIDIFIER, MODEL HA50 (March 7, 2001)
K001553 — BREAS PV 100 CPAP SYSTEM (August 3, 2000)
K000441 — BODYGUARD (April 11, 2000)
K990412 — CUFF-ABLE PLUS (September 1, 1999)
K984468 — VITAL PEP (June 1, 1999)

Other clearances for product code DXQ

K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-12 (February 13, 2026)
K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N) (January 9, 2026)
K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (December 16, 2025)
K250765 — AViTA Arm Type Blood Pressure Monitor Cuff (September 3, 2025)
K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U168 (July 15, 2025)
K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (October 31, 2024)
K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (March 20, 2024)
K233276 — Reusable Blood Pressure Cuff (December 21, 2023)
K232772 — Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,120 (November 29, 2023)
K231961 — NIBPCuff (August 30, 2023)