Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mortara Instrument, Inc. · Predicate Candidate Screening
51 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
264 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182297 | Surveyor S2 | Mortara Instrument, Inc. | 2019-01-24 | 153 | 0 |
| K173765 | Surveyor Patient Monitor | Mortara Instrument, Inc. | 2018-09-04 | 267 | 1 |
| K161517 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2017-01-11 | 223 | 0 |
| K161465 | CardioConfirm | Mortara Instrument, Inc. | 2016-09-03 | 99 | 0 |
| K160685 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2016-08-04 | 146 | 1 |
| K152626 | H3+ Holter Recorder | Mortara Instrument, Inc. | 2016-02-26 | 164 | 0 |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exe | Mortara Instrument, Inc. | 2016-01-06 | 92 | 5 |
| K141020 | SURVEYOR S4 MOBILE MONITOR | Mortara Instrument, Inc. | 2014-12-03 | 226 | 0 |
| K133989 | AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | Mortara Instrument, Inc. | 2014-11-25 | 334 | 0 |
| K141811 | MORTARA MONITORING WAVEFORM VIEWER | Mortara Instrument, Inc. | 2014-11-19 | 135 | 0 |
| K142105 | ELI 380 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2014-09-05 | 35 | 2 |
| K131929 | SURVEYOR CENTRAL STATION | Mortara Instrument, Inc. | 2013-12-03 | 159 | 0 |
| K123556 | MORTARA SURVEYOR PATIENT MONITOR | Mortara Instrument, Inc. | 2013-03-22 | 123 | 1 |
| K122073 | ELI 280 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2012-08-02 | 17 | 0 |
| K120865 | RSCRIBE ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2012-07-19 | 119 | 1 |
| K102206 | ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 | Mortara Instrument, Inc. | 2011-02-18 | 197 | 1 |
| K101403 | ELI 250 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2010-07-02 | 44 | 1 |
| K101115 | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 | Mortara Instrument, Inc. | 2010-06-18 | 58 | 1 |
| K100127 | ELI 230 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2010-04-16 | 87 | 1 |
| K093339 | ELI PC ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2010-02-19 | 116 | 1 |
| K092663 | ELI 350 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2009-12-14 | 105 | 1 |
| K082946 | MORTARA ELI 350 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2008-12-29 | 88 | 0 |
| K081800 | T12S TELEMETRY TRANSMITTER | Mortara Instrument, Inc. | 2008-09-24 | 91 | 1 |
| K070539 | MORTARA ELI 10 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2007-03-15 | 17 | 0 |
| K062677 | ELI 350 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2006-11-15 | 68 | 0 |
| K060135 | MORTARA SURVEYOR TELEMETRY CENTRAL STATION | Mortara Instrument, Inc. | 2006-05-15 | 116 | 0 |
| K050896 | H12+ HOLTER RECORDER | Mortara Instrument, Inc. | 2005-08-24 | 138 | 1 |
| K043010 | HOLTER RECORDER H3+ | Mortara Instrument, Inc. | 2005-02-25 | 116 | 0 |
| K031182 | ELI 200+ AUDICOR | Mortara Instrument, Inc. | 2003-07-25 | 101 | 0 |
| K022618 | X-SCRIBE II | Mortara Instrument, Inc. | 2002-09-06 | 30 | 0 |
| K021373 | H12+HOLTER RECORDER | Mortara Instrument, Inc. | 2002-06-27 | 57 | 0 |
| K004017 | H-SCRIBE | Mortara Instrument, Inc. | 2001-06-11 | 166 | 2 |
| K974149 | AMBULATORY X-12 TELEMETRY MODULE | Mortara Instrument, Inc. | 1998-01-08 | 65 | 1 |
| K942685 | ECG REVIEW STATION | Mortara Instrument, Inc. | 1997-08-12 | 1162 | 0 |
| K933143 | MODEL ELI 300 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 1994-04-15 | 291 | 0 |
| K930558 | MORTARA INSTRUMENT, INC. E-SCRIBE | Mortara Instrument, Inc. | 1993-04-27 | 83 | 0 |
| K922927 | MORTARA INSTRUMENT ST CENTRAL STATION | Mortara Instrument, Inc. | 1992-11-10 | 146 | 0 |
| K915730 | MORTARA INSTRUMENT ODEL ELI 50I | Mortara Instrument, Inc. | 1992-11-10 | 326 | 0 |
| K920626 | MODEL ELI 200 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 1992-09-04 | 219 | 0 |
| K920627 | MODEL ELI 100 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 1992-09-04 | 219 | 0 |
| K920377 | MORTARA INSTRUMENT MODEL ECG PREVU | Mortara Instrument, Inc. | 1992-04-28 | 90 | 0 |
| K911097 | PR4 | Mortara Instrument, Inc. | 1991-08-07 | 148 | 0 |
| K900720 | MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED) | Mortara Instrument, Inc. | 1990-11-05 | 264 | 0 |
| K902652 | MORTARA INSTRUMENT MODEL ELI 50 | Mortara Instrument, Inc. | 1990-08-23 | 69 | 0 |
| K895232 | MODEL ELI-100/ST ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 1989-12-13 | 114 | 0 |
| K880664 | MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED) | Mortara Instrument, Inc. | 1988-03-09 | 20 | 0 |
| K864580 | MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM) | Mortara Instrument, Inc. | 1987-02-20 | 92 | 0 |
| K861850 | BURDICK DIVISION (E-500) | Mortara Instrument, Inc. | 1986-08-28 | 106 | 0 |
| K861851 | SIEMENS-ELEMA (SICARD-P) | Mortara Instrument, Inc. | 1986-08-28 | 106 | 0 |
| K851702 | MORTARA INSTRUMENT MODEL EL-1 | Mortara Instrument, Inc. | 1985-07-29 | 96 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda