Engineered Medical Systems: FDA filings under this applicant name
FDA lists 24 510(k) clearances under 2 spellings of the applicant name “Engineered Medical Systems” (first 1987, latest 2022), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 138 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 | 1 | 265 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Engineered Medical Systems took a median 265 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 204 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 6 | 6 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 | 3 |
| BSJ | Mask, Gas, Anesthetic | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| BYI | Percussor, Powered-Electric | 1 | 1 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent Engineered Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220533 | Endoscopy Oxygen Mask | CCK | 2022-11-16 | 265 |
| K062104 | TALKING TRACH | BTO | 2007-04-20 | 270 |
| K023683 | MULTI-STRAP FULL FACE MASK | BZD | 2003-12-01 | 395 |
| K013728 | TRACH VOX | JOH | 2002-07-30 | 263 |
| K013122 | EMS ELECTROSTATIC FLITER AND HME COMBINATION | CAH | 2002-04-19 | 212 |
| K013123 | EMS PULMONARY FUNCTION TESTING FILTER | BZG | 2002-03-14 | 176 |
| K013089 | EMS HEPA FILTER AND HME COMBINATIONS | CAH | 2002-03-14 | 178 |
| K003497 | DISPOSABLE PRESSURE MONITOR | CAP | 2000-11-30 | 17 |
| K000215 | SWIVEL ELBOW | BZD | 2000-05-26 | 123 |
| K000314 | INCENTIVE SPIROMETER | BWF | 2000-04-12 | 71 |
14 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-09-12.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Engineered Medical Systems (22)
- Engineered Medical Systems, Inc. (2)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Engineered Medical Solutions Co., LLC (2 510(k)s)
- Engineered Orthopedic Technologies, Inc. (2 510(k)s)
- Engineered Custom Mfg., Inc. (1 510(k)s)
- Engineered Endodontics (1 510(k)s)
- Engineered Medical Technology, Inc. (1 510(k)s)
- Engineered Tissue Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Engineered Medical Systems?
FDA lists 24 510(k) clearances under 2 spellings of the applicant name “Engineered Medical Systems” (first 1987, latest 2022), across 14 product codes in 3 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 Engineered Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Engineered Medical Systems is 138 days.
Which FDA product codes appear under Engineered Medical Systems?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 6); BZD (Ventilator, Non-Continuous (Respirator), 3); BSJ (Mask, Gas, Anesthetic, 2).
Next steps
- See all 24 Engineered Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code BTM, Engineered Medical Systems'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.