510(k) · Cleared
ClearedHeine Gamma G7; Heine Gamma G5, Heine Gamma GP, Heine Gamma GST, Heine Gamma XXL LF Model M-000.09.23X, M-000.09.24X, M-
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heine Optotechnik GmbH & Co. KG · DXQ Blood Pressure Cuff
Cleared on Aug 27, 2010 as substantially equivalent to K972379 (Rudolf Riester GmbH & Co. KG, 1997) and 3 other predicates after a 51-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Aug 27, 2010
- Review
- 51 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K972301 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972301 Big Ben Square, Big Ben RoundRudolf Riester GmbH & Co. KG · 1997
- This deviceK101892 Heine Gamma G7; Heine Gamma G5, Heine Gamma GP, Heine Gamma GST…Heine Optotechnik GmbH & Co. KG · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972301 | Big Ben Square, Big Ben Round | Rudolf Riester GmbH & Co. KG | 1997 | — |
| 0 (this device) | K101892 | Heine Gamma G7; Heine Gamma G5, Heine Gamma GP, Heine Gamma GST, Heine Gamma… | Heine Optotechnik GmbH & Co. KG | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K972379 | Precisa NSummary page 2…Device Trade Name: Riester Precisa N Applicant: RUDOLF RIESTER GMBH & C0. KG 51 0(k) No.: K972379 2. Device Trade Name: Riester Risan Applicant: RUDOLF RIESTER GMBH… | 1997 |
| * | K002954 | RI-San/RI-Sana Blood Pressure ManometersSummary page 2…Device Trade Name: Riester Risan Applicant: RUDOLF RIESTER GMBH & CO. KG 51 0(k) No.: K002954 3. Device Trade Name: Riester Big Ben Applicant: RUDOLF RIESTER GM… | 2000 |
| * | K972301 | Big Ben Square, Big Ben RoundSummary page 2…Device Trade Name: Riester Big Ben Applicant: RUDOLF RIESTER GMBH & CO. KG 51 0(k) No.: K972301 4. Device Trade Name: Riester Sanaphon Applicant: RUDOLF RIESTER G… | 1997 |
| * | K972378 | Sanaphon NSummary page 2…Device Trade Name: Riester Sanaphon Applicant: RUDOLF RIESTER GMBH & CO. KG 51 0(k) No.: K972378 The H-EINE GAMMA aneroid sphygmomanometers are considered substantial equivalent to the Riester Precisa N (K9723… | 1997 |
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?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K972379.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
HEINE GAMMA aneroid sphygmomanometers are exclusively designed for measuring blood pressure at the upper arm or thigh on healthy skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101892: Heine Gamma G7; Heine Gamma G5, Heine Gamma GP, Heine Gamma GST, Heine Gamma XXL LF Model M-000.09.23X, M-000.09.24X, M-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101892
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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