Honeywell, Inc.: FDA clearances and approvals
Honeywell, Inc. has 69 FDA 510(k) clearances (first 1976, latest 1990), across 29 product codes in 8 review panels. Median 510(k) review time: 34 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 7 | 7 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 6 | 6 |
| DSF | Recorder, Paper Chart | 6 | 6 |
| DSK | Computer, Blood-Pressure | 4 | 4 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 4 | 4 |
| DXJ | Display, Cathode-Ray Tube, Medical | 4 | 4 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 4 | 4 |
| BZQ | Monitor, Breathing Frequency | 3 | 3 |
| DRJ | System, Signal Isolation | 3 | 3 |
| DXK | Echocardiograph | 3 | 3 |
Plus 19 more product codes.
Review panels
- Cardiovascular (51)
- Anesthesiology (5)
- Radiology (3)
- Gastroenterology and Urology (2)
- Neurology (2)
- Pathology (2)
- Hematology (1)
- General Hospital (1)
Most recent Honeywell, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902230 | COLORADO COLOR IMAGING RECORDER | DSF | 1990-06-19 | 33 |
| K863100 | CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR | DPS | 1987-02-03 | 174 |
| K853501 | HONEYWELL ELECTRONIC VENTILATOR EV-A | CBK | 1986-04-04 | 227 |
| K855125 | PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM | DRT | 1986-03-26 | 93 |
| K851888 | APM DISPOS. BLOOD PRESSURE TRANSDUCER | DRS | 1985-08-06 | 97 |
| K851496 | ECG MONITOR MODEL RM102 | DXJ | 1985-07-24 | 100 |
| K850794 | PATIENT MONITOR MODEL RM-300 | DTR | 1985-04-18 | 51 |
| K851092 | PORTABLE DEFIBRILLATOR/MONITOR ED 425 | LDD | 1985-04-10 | 22 |
| K834530 | EXTENSION BOX EB200 | DRT | 1984-06-01 | 163 |
| K834282 | ULTRA IMAGER 2000 | IYO | 1984-04-23 | 154 |
59 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Honeywell, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Honeywell, Inc. have?
Honeywell, Inc. has 69 FDA 510(k) clearances (first 1976, latest 1990), across 29 product codes in 8 review panels.
How long does FDA take to clear Honeywell, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Honeywell, Inc.'s cleared 510(k)s is 34 days.
What devices does Honeywell, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 7); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 6); DSF (Recorder, Paper Chart, 6).
Has Honeywell, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Honeywell, Inc. Related entities may recall under other names.
Next steps
- See all 69 Honeywell, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Honeywell, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.