510(k) · Cleared
ClearedMedical Air Compressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oricare, Inc. · BTI Compressor, Air, Portable
Cleared on Aug 10, 2012 after a 270-day review. The FDA summary names no predicate by number.
- Decided
- Aug 10, 2012
- Review
- 270 days
- Class
- Class II
- Product code
- BTI
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All BTI devicesBTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · BTI
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · BTI
Too few BTI 510(k)s in any year since 2007 to give a median.
Recalls per year · BTI
3in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · BTI
120in 2025
MAUDE reports naming product code BTI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 18 |
| 2008 | 1 | — | 0 | 9 |
| 2009 | 1 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 217 |
| 2013 | 1 | — | 1 | 1,710 |
| 2014 | 0 | — | 0 | 982 |
| 2015 | 0 | — | 0 | 294 |
| 2016 | 0 | — | 0 | 139 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 0 | — | 0 | 114 |
| 2020 | 0 | — | 0 | 111 |
| 2021 | 0 | — | 0 | 278 |
| 2022 | 0 | — | 0 | 248 |
| 2023 | 0 | — | 3 (3) | 325 |
| 2024 | 0 | — | 0 | 166 |
| 2025 | 0 | — | 0 | 120 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Oricare 04500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator that operates within the C4500 Compressor manufacturer specifications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113338: Medical Air Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113338
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026