Preceptis Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Preceptis Medical” (first 2014, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 86 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 |
|---|---|---|
| 2014 | 1 | 242 |
| 2015 | 2 | 164 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 57 |
| 2021 | 0 | — |
| 2022 | 1 | 86 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Preceptis Medical took a median 72 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETD | Tube, Tympanostomy | 5 | 5 |
Review panels
Most recent Preceptis Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221254 | Hummingbird Tympanostomy Tube System | ETD | 2022-07-27 | 86 |
| K200952 | Hummingbird Tympanostomy Tube System | ETD | 2020-06-05 | 57 |
| K151830 | Hummingbird Tympanostomy Tube | ETD | 2015-09-21 | 77 |
| K142282 | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | ETD | 2015-04-23 | 251 |
| K133921 | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | ETD | 2014-08-22 | 242 |
Recalls
openFDA lists no recalls under a recalling firm named Preceptis Medical.
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 Preceptis Medical is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03544138: In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old (Completed, started 2018-07-24)
- NCT03503591: Study of the Hummingbird TTS™ Tympanostomy Tube System (Completed, started 2016-01-29)
- NCT02165384: Hummingbird TTS Ear Tube Delivery Study (Completed, started 2014-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Preceptis Medical?
FDA lists 5 510(k) clearances under the applicant name “Preceptis Medical” (first 2014, latest 2022), across 1 product code 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 Preceptis Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Preceptis Medical is 86 days.
Which FDA product codes appear under Preceptis Medical?
The most frequent FDA product codes under this applicant name are ETD (Tube, Tympanostomy, 5).
Next steps
- See all 5 Preceptis Medical clearances with predicates and recalls
- Run predicate analysis for product code ETD, Preceptis Medical'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.