Kellerandheckman: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Kellerandheckman” (first 1998, latest 1998), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 307 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 |
|---|---|---|---|
| MED | Sterilant, Medical Devices | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (1)
Most recent Kellerandheckman 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974188 | CETYLCIDE-G | MED | 1998-09-10 | 307 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N80023 | PMA | ABSORBABLE DUSTING POWDER | 1972-08-02 |
Recalls
openFDA lists no recalls under a recalling firm named Kellerandheckman.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kellerandheckman?
FDA lists 1 510(k) clearance under the applicant name “Kellerandheckman” (first 1998, latest 1998), plus 1 PMA decision, across 2 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 Kellerandheckman?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kellerandheckman is 307 days.
Which FDA product codes appear under Kellerandheckman?
The most frequent FDA product codes under this applicant name are MED (Sterilant, Medical Devices, 1).
Next steps
- See all 1 Kellerandheckman clearances with predicates and recalls
- Run predicate analysis for product code MED, Kellerandheckman'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.