Mortara Instrument, Inc.: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Mortara Instrument, Inc.” (first 1983, latest 2019), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 223 days, against 175 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 68 |
| 2013 | 2 | 141 |
| 2014 | 4 | 180 |
| 2015 | 0 | — |
| 2016 | 4 | 122 |
| 2017 | 1 | 223 |
| 2018 | 1 | 267 |
| 2019 | 1 | 153 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mortara Instrument, Inc. took a median 223 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 21 | 21 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 7 | 7 |
| LOS | 6 | 6 | |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 3 | 3 |
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
Plus 3 more product codes.
Review panels
- Cardiovascular (44)
- Anesthesiology (1)
Most recent Mortara Instrument, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182297 | Surveyor S2 | DRG | 2019-01-24 | 153 |
| K173765 | Surveyor Patient Monitor | MHX | 2018-09-04 | 267 |
| K161517 | Mortara Surveyor Patient Monitor | MHX | 2017-01-11 | 223 |
| K161465 | CardioConfirm | DQK | 2016-09-03 | 99 |
| K160685 | Surveyor S4 Mobile Monitor | MHX | 2016-08-04 | 146 |
| K152626 | H3+ Holter Recorder | MWJ | 2016-02-26 | 164 |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems | DPS | 2016-01-06 | 92 |
| K141020 | SURVEYOR S4 MOBILE MONITOR | DRG | 2014-12-03 | 226 |
| K133989 | AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | DXN | 2014-11-25 | 334 |
| K141811 | MORTARA MONITORING WAVEFORM VIEWER | MHX | 2014-11-19 | 135 |
41 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-05-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Mortara Instrument, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02571686: Accuracy of Pulse Oximeters With Profound Hypoxia (Completed, started 2015-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mortara Instrument, Inc.?
FDA lists 51 510(k) clearances under the applicant name “Mortara Instrument, Inc.” (first 1983, latest 2019), across 13 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mortara Instrument, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mortara Instrument, Inc. is 116 days. Since 2017: 223 days, versus 175 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mortara Instrument, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 21); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 7); LOS (device, 6).
Next steps
- See all 51 Mortara Instrument, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Mortara Instrument, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.