# K050896: H12+ Holter Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Aug 24, 2005 after 138 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911097 (1991). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911097: PR4, Mortara Instrument, Inc. (1991) Summary page 1.

## Most influential descendants
- K091505: COR12+ (2009), 6 descendants of its own
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K151787: Holter System (2016), 2 descendants of its own
- K181524: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (2018), 1 descendant of its own
- K254119: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) (2026), 0 descendants of its own

## Recalls of this device
- Mar 18, 2020 · Class II · Z-1812-2020: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## Indications for use
The H 12+ Holter recorder is intended to acquire, record and store ECG data of patients thathave been connected to the Mortara H 12+ recorder and are undergoing Holter monitoring. The Hi 2+ acquires, digitizes and stores data to be analyzed by the H-Scribe Hoiter system. The H12+ is indicated for use: * in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 48 hours. * The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Hotter analysis system (K004017). ECG data prerecorded by the HI12+ is acquired and analyzed by the H-Scribe.

Source page: https://510kreport.com/device/K050896
Methodology: https://510kreport.com/methodology