Pelton & Crane Co.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under 2 spellings of the applicant name “Pelton & Crane Co.” (first 1976, latest 2018), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 79 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 | 1 | 268 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 307 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pelton & Crane Co. took a median 307 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIA | Unit, Operative Dental | 5 | 5 |
| EAP | Unit, X-Ray, Intraoral | 3 | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| KLC | Chair, Dental, With Operative Unit | 2 | 2 |
| EAZ | Light, Operating, Dental | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| FLE | Sterilizer, Steam | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (9)
- Radiology (5)
- General Hospital (1)
Most recent Pelton & Crane Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171872 | P50 Series Dental Operative Unit and Accessories | EIA | 2018-04-26 | 307 |
| K143696 | Spirit | EIA | 2015-09-18 | 268 |
| K972249 | ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD | EHD | 1997-09-12 | 88 |
| K972168 | SIDEXIS DIGITAL RADIOGRAPHY SYSTEM | EHD | 1997-09-05 | 88 |
| K945117 | DELTA | FLE | 1997-02-28 | 864 |
| K962071 | SPIRIT S1/S2 | EIA | 1996-08-06 | 70 |
| K960819 | HELIODENT DS | EAP | 1996-03-29 | 29 |
| K950299 | CEREC 2 | ELW | 1995-05-23 | 118 |
| K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER | EIA | 1995-03-01 | 71 |
| K950030 | HELIODENT MD | EAP | 1995-02-03 | 30 |
6 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2012-02-20.
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:
- Pelton & Crane Co. (14)
- Pelton & Crane (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pelton & Crane Co.?
FDA lists 16 510(k) clearances under 2 spellings of the applicant name “Pelton & Crane Co.” (first 1976, latest 2018), across 8 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 Pelton & Crane Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pelton & Crane Co. is 79 days.
Which FDA product codes appear under Pelton & Crane Co.?
The most frequent FDA product codes under this applicant name are EIA (Unit, Operative Dental, 5); EAP (Unit, X-Ray, Intraoral, 3); EHD (Unit, X-Ray, Extraoral With Timer, 2).
Next steps
- See all 16 Pelton & Crane Co. clearances with predicates and recalls
- Run predicate analysis for product code EIA, Pelton & Crane Co.'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.