# K955015: Zymed Holter Scanner Model 2010

- Pathway: 510(k) (Traditional)
- Applicant: Zymed Medical Instrumentation
- Decided: Mar 18, 1996 after 138 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930806 (1994). 1 ancestor in all.
108 later devices descend from it; 5 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930806: Zymed Holter Scanner Model 2010, Agilent Technologies (1994) Summary page 1.

## Most influential descendants
- K990170: Holter 2000 (1999), 89 descendants of its own
- K010949: 2010 Plus Holter for Windows (2001), 85 descendants of its own
- K042108: Vista Plus (2005), 46 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own

## Indications for use
The Model 2010 Plus was designed for the busy Holter environment that places a premium on throughput analysis. This powerful computer provides the “muscle” to analyze even the most difficult recordings quickly and accurately. Three channels of recorded patient ECG are utilized by the sophisticated arrhythmia analysis program to detect abnormalities. The system provides a number of clinical tools such as individual ECG printouts, trend data analysis, HRV time domain, and full disclosure to enable the clinician to review a patients cardiac performance. The 2010-Plus gives the flexibility to process Holter recordings prospectively or retrospectively. Prospective interaction lets the technician supervise the analysis by viewing the ECG chronologically and fine-tuning the arrhythmia processor on-line for error-free results. Superimposition, paging, or a combination of both techniques can be used for prospective scanning. Or. the system can automatically analyze the data in approximately 12 minutes. Once the preliminary analysis is complete, the technician can use powerful retrospective tools to validate and edit the report.

Source page: https://510kreport.com/device/K955015
Methodology: https://510kreport.com/methodology