Cleen-Able
FDA 510(k) K994044 · Vital Signs, Inc.
510(k) numberK994044
Submission
- Device name
- Cleen-Able
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- November 29, 1999
- Decision date
- February 25, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXQ – Blood Pressure Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1120
- Specialty
- Cardiovascular
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 510(k)s with product code DXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | Medline Industries, LP | 06/22/2026SE |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ · Traditional | Nihon Kohden Corporation | 05/06/2026SE |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122…DXQ · Traditional | Shenzhen Best Electronics Co., Ltd. | 02/13/2026SE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special | Unimed Medical Supplies, Inc. | 01/09/2026SE |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | Baxter Healthcare Corporation | 12/16/2025SE |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | Avita Corporation | 09/03/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | Unimed Medical Supplies, Inc. | 07/15/2025SE |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuffDXQ · Traditional | Shenzhen Medke Technology Co., Ltd. | 10/31/2024SE |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerDXQ · Traditional | Wenzhou Longwan Medical Device Factory | 03/20/2024SE |
| K233276 | Reusable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 12/21/2023SE |
More from Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K112902 | Enflow IV Fluid WarmerLGZ · Traditional | 03/14/2012SE |
| K041309 | Imask TMBZD · Traditional | 06/30/2004SE |
| K030985 | Breas PV 10I CPAP System, Model PV 10IBZD · Traditional | 10/15/2003SE |
| K022402 | Disposable Pressure ManometerCAP · Traditional | 08/22/2002SE |
| K021315 | Sure-LokFMI · Abbreviated | 08/21/2002SE |
| K002454 | Breas HA50 Humidifier, Model HA50BTT · Abbreviated | 03/07/2001SE |
| K001553 | Breas PV 100 CPAP SystemBZD · Traditional | 08/03/2000SE |
| K000441 | BodyguardFMI · Traditional | 04/11/2000SE |
| K990412 | Cuff-Able PlusDXQ · Traditional | 09/01/1999SE |
| K984468 | Vital PepBWF · Traditional | 06/01/1999SE |
Questions and answers
When was Cleen-Able cleared by the FDA?
Cleen-Able (K994044) received a 510(k) decision of Substantially Equivalent on February 25, 2000, 88 days after the submission was received.
What is the product code of K994044?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.