510(k) · Cleared
ClearedErka. Perfect-Aneroid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erka Kallmeyer Medizintechnik GmbH · DXQ Blood Pressure Cuff
Cleared on Jun 8, 2011 as substantially equivalent to K972379 (Rudolf Riester GmbH & Co. KG, 1997) and 2 other predicates after a 177-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jun 8, 2011
- Review
- 177 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K884421 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
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) | K103637 | Erka. Perfect-Aneroid | Erka Kallmeyer Medizintechnik GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 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? (3)
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 1…ate Device: RUDOLF RIESTER PRECISA N Blood Pressure Sphygmomanometer 510(k) Document Control No.: K972379 (4) Description of the device: The ERKA. Perfect-Aneroid Sphygmomanometer is an established manual non- invasive blood pressure… | 1997 |
| * | K071885 | Antimicrobial and Single-Patient CuffsSummary page 2…f is made of polyurethane material. The cuffs meet the required biocompatibility standards and are substantially equivalent to the cuffs marketed under 510O(k) clearance K071885 and K001 333. The cuffs may be obtained in the following sizes: - Pediatric: Limb circumference 14 cm -21.5 cm - Small a… | 2007 |
| * | K001333 | Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact…Summary page 2…polyurethane material. The cuffs meet the required biocompatibility standards and are substantially equivalent to the cuffs marketed under 510O(k) clearance K071885 and K001 333. The cuffs may be obtained in the following sizes: - Pediatric: Limb circumference 14 cm -21.5 cm - Small adult: Limb ci… | 2000 |
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 22 years and passes through 3 companies; a new generation was cleared every 18.9 years on median.
- None of the 5 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. 2011, 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 ERKA. Perfect-Aneroid sphygmomanometer is intended for the non-invasive blood pressure measurement of adult and paediatric, but not neonatal patients. The device is not designed, sold or intended for use except as indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103637: Erka. Perfect-Aneroid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103637
Report an extraction error
Are you the manufacturer?
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