Celleration, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under 2 spellings of the applicant name “Celleration, Inc.” (first 2005, latest 2014), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 118 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 | 1 | 17 |
| 2013 | 0 | — |
| 2014 | 1 | 135 |
| 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 |
|---|---|---|---|
| NRB | Wound Cleaner, Ultrasound | 4 | 3 |
Review panels
Most recent Celleration, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140782 | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR | NRB | 2014-08-13 | 135 |
| K122246 | MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 | NRB | 2012-08-13 | 17 |
| K050129 | CELLERATION MIST THERAPY SYSTEM 5.1 | NRB | 2005-05-17 | 118 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN040004 | De Novo | Wound Cleaner, Ultrasound | 2004-06-25 |
Recalls
openFDA lists no recalls under a recalling firm named Celleration, 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.
Device clinical trials
An industry sponsor named Celleration, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01549860: Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers (Completed, started 2012-04)
- NCT01214980: Split Thickness Donor Site Healing With MIST Study (Completed, started 2012-02)
- NCT01206855: Effectiveness Study of MIST Therapy After Cosmetic Surgery Procedures of the Face and Body (Completed, started 2010-10)
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:
- Celleration, Inc. (3)
- Celleration (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Celleration, Inc.?
FDA lists 3 510(k) clearances under 2 spellings of the applicant name “Celleration, Inc.” (first 2005, latest 2014), plus 1 De Novo decision, 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 Celleration, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Celleration, Inc. is 118 days.
Which FDA product codes appear under Celleration, Inc.?
The most frequent FDA product codes under this applicant name are NRB (Wound Cleaner, Ultrasound, 4).
Next steps
- See all 3 Celleration, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NRB, Celleration, 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 (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.