# Mortara Instrument, Inc.

- Location (FDA's records): Milwaukee, WI
- FDA decisions: 51 (1983–2019): 51 510(k) clearances
- Product codes: DPS (21), MHX (7), LOS (6), MWJ (3), DSI (3), DRG (3), DSH (2), DRT (1), MLO (1), DQK (1), DXN (1), DXJ (1)
- 510(k) review time since 2016: median 150 days, against 170 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 61 (41 its own); citations of its devices by later devices: 66 (41 its own)
- Recalls linked to its devices: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Quinton, Inc.: 2 (https://510kreport.com/company/quinton)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)
- Spacelabs Healthcare Medical Equipment (Suzhou) CO: 1 (https://510kreport.com/company/spacelabs-healthcare-medical-equipment-suzhou)
- Schiller AG: 1 (https://510kreport.com/company/schiller)
- Hewlett-Packard Co.: 1 (https://510kreport.com/company/hewlett-packard)
- Marquette Electronics, Inc.: 1 (https://510kreport.com/company/marquette-electronics)
- Inovise Medical, Inc.: 1 (https://510kreport.com/company/inovise-medical)
- Cardiodata Corp.: 1 (https://510kreport.com/company/cardiodata)

## Firms that cite its devices most
- Ge Medical Systems Information Technologies: 3 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Cardioline S.P.A: 3 (https://510kreport.com/company/cardioline)
- Inovise Medical, Inc.: 2 (https://510kreport.com/company/inovise-medical)
- Edan Instruments, Inc.: 2 (https://510kreport.com/company/edan-instruments)
- Tapuz Medical Technology, Ltd.: 1 (https://510kreport.com/company/tapuz-medical-technology)
- Global Instrumentation, LLC: 1 (https://510kreport.com/company/global-instrumentation)
- Ela Medical, Inc.: 1 (https://510kreport.com/company/ela-medical)
- Cardiac Science Corporation: 1 (https://510kreport.com/company/cardiac-science)

## Its most-cited devices
- K974149: Ambulatory X-12 Telemetry Module (1998), cited by 7
- K082946: Mortara Eli 350 Electrocardiograph (2008), cited by 7
- K031182: Eli 200+ Audicor (2003), cited by 5
- K021373: H12+Holter Recorder (2002), cited by 4
- K050896: H12+ Holter Recorder (2005), cited by 2
- K060135: Mortara Surveyor Telemetry Central Station (2006), cited by 2

## Recent decisions
- K182297: Surveyor S2 (Jan 24, 2019)
- K173765: Surveyor Patient Monitor (Sep 4, 2018)
- K161517: Mortara Surveyor Patient Monitor (Jan 11, 2017)
- K161465: CardioConfirm (Sep 3, 2016)
- K160685: Surveyor S4 Mobile Monitor (Aug 4, 2016)
- K152626: H3+ Holter Recorder (Feb 26, 2016)
- K152944: Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems (Jan 6, 2016)
- K141020: Surveyor S4 Mobile Monitor (Dec 3, 2014)

Source page: https://510kreport.com/company/mortara-instrument