510(k) · Cleared
ClearedValue Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DXQ Blood Pressure Cuff
Cleared on Oct 27, 2015 as substantially equivalent to K071885 (Philips Medical Systems, 2007) after a 68-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Oct 27, 2015
- Review
- 68 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K884421 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK884421 Pre-Gaged Balanced Cuff W/Sylgard Antimicro. TreatPymah Corp. · 1989
- 1 generation backK071885 Antimicrobial and Single-Patient CuffsPhilips Medical Systems · 2007
- This deviceK152363 Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long)…Philips Medical Systems · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884421 | Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat | Pymah Corp. | 1989 | — |
| −1 | K071885 | Antimicrobial and Single-Patient Cuffs | Philips Medical Systems | 2007 | — |
| 0 (this device) | K152363 | Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care… | Philips Medical Systems | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K071885 | Antimicrobial and Single-Patient CuffsSummary page 5…Date Device Owner/ Trade Models Manufacturer Name K071885 12/20/2007 Philips Series of Multi- Philips Medical Easy M4552B, M4553B, M4554B, M4555B,… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 2 companies; a new generation was cleared every 18.9 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K071885.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Philips multi-patient and single-patient cuffs are intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the non-invasive measurement of infant, pediatric, and adult human blood pressure.
Philips air hoses are intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the noninvasive measurement of neonatal, pediatric, and adult human blood pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152363: Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152363
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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