510(k) · Cleared
ClearedNBP Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical AG & Co. KG · DXQ Blood Pressure Cuff
Cleared on Nov 24, 2009 as substantially equivalent to K022889 (Siemens Medical Solutions USA, Inc., 2002) and 3 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Nov 24, 2009
- Review
- 57 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K946306 (1995). 25 ancestors in all, the oldest K790810 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 3 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 1 generation backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- This deviceK092999 NBP CuffDraeger Medical AG & Co. KG · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −3 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −1 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K092999 | NBP Cuff | Draeger Medical AG & Co. KG | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Summary page 2…is claimed: Siemens Infinity Modular Monitors, Models Dr~ger Medical System, Inc SC 8000, SC 7000 & SC 9000XL & Siemens K022889 Infinity Explorer (former Siemens Medical (cuffs from supplier Statc… | 2002 |
| * | K022482 | Sensa-Cuff, Models Infant, Child, AdultSummary page 2…89 Infinity Explorer (former Siemens Medical (cuffs from supplier Statcorp) Solutions USA, Inc.) K022482 Sensa-Cuf GE Medical Systems Information… | 2002 |
| * | K974080 | Critikon Soft Blood Pressure CuffSummary page 2…482 Sensa-Cuf GE Medical Systems Information Technologies K974080 Critikon Soft Blood Pressure Cuff Johnson & Johnson Medical, Inc. Preamendent Critikon Dura-Cuf`… | 1998 |
| * | K991525 | Deroyal Sterile Neonatal Blood Pressure CuffSummary page 2…Critikon Soft Blood Pressure Cuff Johnson & Johnson Medical, Inc. Preamendent Critikon Dura-Cuf` Critikon Company, LLC K991525 Sterile Neonatal Blood Pressure Cuff Deroyal Industries, Inc. Device Description: The devices comprise tubin… | 1999 |
| * | — | Critikon Dura-Cuf Named without a submission number |
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 14 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 25 ancestors have a recall of any class.
- 4 other devices also cite its predicate K022889.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Drfger cuffs are intended to be used for automatic non-invasive blood pressure measurement.
Drfger cuffs are compatible with Dr/ger and Siemens patient monitors.
Neonatal cuffs are designed for single-patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092999: NBP Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092999
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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