510(k) · Cleared
ClearedReusable NIBP Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orantech, Inc. · DXQ Blood Pressure Cuff
Cleared on Aug 21, 2018 as substantially equivalent to K112544 (Unimed Medical Supplies, Inc., 2011) after a 323-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Aug 21, 2018
- Review
- 323 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022482 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK022482 Sensa-Cuff, Models Infant, Child, AdultGe Medical Systems Information Technologies · 2002
- 1 generation backK112544 Unimed Blood Pressure CuffUnimed Medical Supplies, Inc. · 2011
- This deviceK173197 Reusable NIBP CuffOrantech, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK211747 Reusable NIBP CuffShenzhen Coreray Technology Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211747Reusable NIBP CuffShenzhen Coreray Technology Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022482 | Sensa-Cuff, Models Infant, Child, Adult | Ge Medical Systems Information Technologies | 2002 | — |
| −1 | K112544 | Unimed Blood Pressure Cuff | Unimed Medical Supplies, Inc. | 2011 | — |
| 0 (this device) | K173197 | Reusable NIBP Cuff | Orantech, Inc. | 2018 | — |
| +1 | K211747 | Reusable NIBP Cuff | Shenzhen Coreray Technology Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXQ device
- #1 K254287 Medline Reusable Blood Pressure Cuffscore 13.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112544 | Unimed Blood Pressure CuffSummary page 4…ng clearance for Reusable NIBP Cuff. It is comparable to the following legally marketed system: 1. Unimed Medical Supplies Inc. Blood Pressure Cuff under K112544. The subject device has same intended use, same target patient population, same performance effectiveness, perfo… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211747 | Reusable NIBP Cuff | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211747 (Shenzhen Coreray Technology Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K112544.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DXQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXQ
174in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXQ
20in 2025
MAUDE reports naming product code DXQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 3 |
| 2008 | 7 | 118 | 0 | 4 |
| 2009 | 5 | 57 | 0 | 2 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 121 | 1 | 5 |
| 2012 | 4 | 102 | 0 | 7 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 4 | 105 | 0 | 9 |
| 2015 | 10 | 59 | 0 | 23 |
| 2016 | 4 | 217 | 0 | 50 |
| 2017 | 2 | — | 0 | 67 |
| 2018 | 5 | 225 | 0 | 44 |
| 2019 | 3 | 44 | 0 | 41 |
| 2020 | 3 | 207 | 0 | 5 |
| 2021 | 4 | 105 | 0 | 12 |
| 2022 | 4 | 105 | 0 | 3 |
| 2023 | 5 | 79 | 0 | 20 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 3 | 174 | 1 | 20 |
| 2026 | 4 | 102 | 0 | — |
What is it indicated for?
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173197: Reusable NIBP Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173197
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026