# K103637: Erka. Perfect-Aneroid

- Pathway: 510(k) (Traditional)
- Applicant: Erka Kallmeyer Medizintechnik GmbH
- Decided: Jun 8, 2011 after 177 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K884421 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972379: Precisa N, Rudolf Riester GmbH & Co. KG (1997) Summary page 1.
- K071885: Antimicrobial and Single-Patient Cuffs, Philips Medical Systems (2007) Summary page 2.
- K001333: Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Noni, Agilent Technologies Deutschland GmbH (2000) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K103637
Methodology: https://510kreport.com/methodology