DXQClass II
Blood Pressure Cuff
21 CFR 870.1120 / Cardiovascular
DXQ is the FDA product code for Blood Pressure Cuff, a class II device type, regulated under 21 CFR 870.1120. FDA's definition for this code reads: "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". As of , FDA records hold 199 510(k) clearances under this code, the most recent dated , and 27 recalls.
Classification record
- Product code
- DXQ
- Device name
- Blood Pressure Cuff
- FDA definition
- 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.
- Regulation
- 21 CFR 870.1120
- 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
- Yes
- Ingested clearances
- 199
- Ingested recalls
- 27
Clearances, product code DXQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 1 |
| 1978 | 2 |
| 1979 | 4 |
| 1980 | 7 |
| 1981 | 5 |
| 1982 | 5 |
| 1983 | 5 |
| 1985 | 5 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 8 |
| 1991 | 4 |
| 1992 | 1 |
| 1993 | 6 |
| 1994 | 8 |
| 1995 | 7 |
| 1996 | 1 |
| 1997 | 7 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 6 |
| 2001 | 6 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 5 |
| 2006 | 4 |
| 2007 | 2 |
| 2008 | 7 |
| 2009 | 5 |
| 2010 | 2 |
| 2011 | 5 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 10 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 5 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 4 |
| 2022 | 4 |
| 2023 | 5 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 4 |
Applicants with the most clearances
Product code DXQ| Applicant | Clearances |
|---|---|
| Rudolf Riester GmbH & Co. KG | 8 |
| Conphar, Inc. | 6 |
| Abco Dealers, Inc. | 5 |
| GE Medical Systems Information Technologies, Inc. | 4 |
| Unimed Medical Supplies Inc | 4 |
| Welch Allyn Inc | 4 |
| Ethox Corp. | 3 |
| Hewlett-Packard Co. | 3 |
| Howmedica Corp. | 3 |
| MEDLINE INDUSTRIES, LP - Northfield | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.