Eastmed Enterprises, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Eastmed Enterprises, Inc.” (first 1988, latest 1993), across 7 product codes in 1 review panel. 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | 5 | 5 |
| BWB | Forceps, Tube Introduction | 3 | 3 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BSR | Stylet, Tracheal Tube | 1 | 1 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BTQ | Airway, Nasopharyngeal | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
Review panels
- Anesthesiology (13)
Most recent Eastmed Enterprises, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922019 | LARYNGOSCOPE RIGID | CCW | 1993-01-26 | 271 |
| K921128 | ENDOTRACHEAL TUBE STYLET | BSR | 1992-06-02 | 84 |
| K914741 | AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED | CCW | 1992-02-03 | 108 |
| K903618 | ROBERTAZZI NASOPHARYNGEAL AIRWAY | BTQ | 1991-01-08 | 154 |
| K901489 | MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) | CCW | 1990-04-10 | 12 |
| K890342 | AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) | BTO | 1989-04-27 | 94 |
| K884584 | TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS | BWB | 1988-11-14 | 12 |
| K884073 | LARYNGOSCOPE BLADE (ROBERTSHAW STYLE) | CCW | 1988-10-13 | 16 |
| K884072 | 15 MILLIMETER MALE AND FEMALE ADAPTERS | CAI | 1988-10-07 | 10 |
| K882433 | LARYNGOSCOPE RIGID | CCW | 1988-09-02 | 80 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Eastmed Enterprises, Inc..
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.
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.
- Eastmed, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eastmed Enterprises, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Eastmed Enterprises, Inc.” (first 1988, latest 1993), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eastmed Enterprises, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eastmed Enterprises, Inc. is 55 days.
Which FDA product codes appear under Eastmed Enterprises, Inc.?
The most frequent FDA product codes under this applicant name are CCW (Laryngoscope, Rigid, 5); BWB (Forceps, Tube Introduction, 3); BSJ (Mask, Gas, Anesthetic, 1).
Next steps
- See all 13 Eastmed Enterprises, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CCW, Eastmed Enterprises, 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.