Grace Medical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Grace Medical, Inc.” (first 1994, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 | 1 | 99 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 136 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 202 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Grace Medical, Inc. took a median 169 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | 7 | 7 |
| ETD | Tube, Tympanostomy | 5 | 5 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 | 1 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 | 1 |
Review panels
- Ear, Nose and Throat (15)
Most recent Grace Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260266 | Tympendi (810) | KHJ | 2026-08-18 | 202 |
| K232059 | Tympanostomy Tubes | ETD | 2023-11-24 | 136 |
| K161376 | DragonFly Surgical Drill System | ERL | 2016-08-25 | 99 |
| K091187 | GRACE DYNAMIC TORP | ETA | 2009-09-14 | 144 |
| K080070 | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES | ETB | 2008-04-17 | 98 |
| K063374 | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE | ETB | 2006-12-06 | 28 |
| K062672 | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES | ETD | 2006-10-24 | 46 |
| K062385 | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES | ETD | 2006-09-27 | 43 |
| K061853 | GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES | ETB | 2006-08-18 | 49 |
| K060518 | PARTIAL OSSICULAR REPLACEMENT PROSTHESES | ETB | 2006-06-28 | 121 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-04-03.
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 Grace Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05849844: Tympanoseal Clinical Study (Recruiting, started 2024-01-05)
- NCT02918942: Tympanoseal (Tympanic Membrane Device) Clinical Study (Completed, started 2016-10-04)
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.
- Grace River Ent., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Grace Medical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Grace Medical, Inc.” (first 1994, latest 2026), across 5 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 Grace Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Grace Medical, Inc. is 72 days.
Which FDA product codes appear under Grace Medical, Inc.?
The most frequent FDA product codes under this applicant name are ETB (Prosthesis, Partial Ossicular Replacement, 7); ETD (Tube, Tympanostomy, 5); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 1).
Next steps
- See all 15 Grace Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETB, Grace Medical, 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.