J. H. Emerson Co.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “J. H. Emerson Co.” (first 1981, latest 2000), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 55 days. 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 | 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 |
|---|---|---|---|
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 3 | 3 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | 2 |
| IQA | System, Environmental Control, Powered | 2 | 2 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 2 | 2 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
Plus 9 more product codes.
Review panels
- Anesthesiology (12)
- General Hospital (6)
- Physical Medicine (3)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent J. H. Emerson Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002598 | EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING | NHJ | 2000-11-22 | 93 |
| K920910 | OXYGEN POWERED RESUSCITATOR FOR CPR | BTL | 1993-01-12 | 320 |
| K924174 | EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA | NHJ | 1992-11-17 | 90 |
| K902764 | EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM | BYT | 1990-11-19 | 147 |
| K896721 | MODEL 7-AT TREATMENT CHAMBER | LGM | 1990-01-22 | 55 |
| K881808 | EMERSON CHEST RESPIRATOR, MODEL 33-CRE | BYT | 1988-08-04 | 98 |
| K873489 | EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000 | GCX | 1987-12-29 | 120 |
| K872937 | 97-TD EMERSON TIMER/DIMMER CONTROL | IQA | 1987-09-24 | 59 |
| K872936 | 97-D EMERSON DIMMER CONTROL | IQA | 1987-09-24 | 59 |
| K864379 | EMERSON 3MV VOLUME VENTILATOR | CBK | 1986-12-15 | 40 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named J. H. Emerson Co..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under J. H. Emerson Co.?
FDA lists 25 510(k) clearances under the applicant name “J. H. Emerson Co.” (first 1981, latest 2000), across 19 product codes in 6 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 J. H. Emerson Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name J. H. Emerson Co. is 55 days.
Which FDA product codes appear under J. H. Emerson Co.?
The most frequent FDA product codes under this applicant name are BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass), 3); CBK (Ventilator, Continuous, Facility Use, 2); GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 2).
Next steps
- See all 25 J. H. Emerson Co. clearances with predicates and recalls
- Run predicate analysis for product code BYT, J. H. Emerson Co.'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.