Battle Creek Equipment Co.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Battle Creek Equipment Co.” (first 1979, latest 1988), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 67 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 |
|---|---|---|---|
| IOL | Treadmill, Powered | 3 | 3 |
| ISD | Exerciser, Measuring | 2 | 2 |
| IQK | Orthosis, Cervical | 1 | 1 |
| IRT | Pad, Heating, Powered | 1 | 1 |
Review panels
Most recent Battle Creek Equipment Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882264 | BATTLE CREEK PILLOW | IQK | 1988-08-09 | 70 |
| K863884 | PULSESTAR EXERCISE BIKE | ISD | 1986-10-23 | 17 |
| K854147 | BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL | IOL | 1985-12-27 | 77 |
| K854148 | BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL | IOL | 1985-12-17 | 67 |
| K851237 | THERMOPHORE ELECTRIC FOMENTATION UNIT | IRT | 1985-07-29 | 124 |
| K840280 | ROAD RUNNER ELECTRIC TREADMILL | IOL | 1984-02-04 | 12 |
| K791866 | STANDARD HEALTH BIKE MODEL 019 | ISD | 1979-10-04 | 13 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-09-15.
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 Battle Creek Equipment Co.?
FDA lists 7 510(k) clearances under the applicant name “Battle Creek Equipment Co.” (first 1979, latest 1988), across 4 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 Battle Creek Equipment Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Battle Creek Equipment Co. is 67 days.
Which FDA product codes appear under Battle Creek Equipment Co.?
The most frequent FDA product codes under this applicant name are IOL (Treadmill, Powered, 3); ISD (Exerciser, Measuring, 2); IQK (Orthosis, Cervical, 1).
Next steps
- See all 7 Battle Creek Equipment Co. clearances with predicates and recalls
- Run predicate analysis for product code IOL, Battle Creek Equipment 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, 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.