# K911097: PR4

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Aug 7, 1991 after 148 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021373: H12+Holter Recorder (2002), 11 descendants of its own
- K050896: H12+ Holter Recorder (2005), 10 descendants of its own
- K091505: COR12+ (2009), 6 descendants of its own
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K043010: Holter Recorder H3+ (2005), 4 descendants of its own

Source page: https://510kreport.com/device/K911097
Methodology: https://510kreport.com/methodology