510(k) · Cleared
ClearedEmg Triton -Comp,Model NCA01-XXX Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emg Technology Co., Ltd. · BTI Compressor, Air, Portable
Cleared on Nov 19, 2008 as substantially equivalent to K781213 (The John Bunn Co., 1978) and 2 other predicates after a 428-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Nov 19, 2008
- Review
- 428 days
- Class
- Class II
- Product code
- BTI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K781213 (1978). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK781213 Compressor, Air, Mini-SilentThe John Bunn Co. · 1978
- This deviceK072634 Emg Triton -Comp,Model NCA01-XXX SeriesEmg Technology Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781213 | Compressor, Air, Mini-Silent | The John Bunn Co. | 1978 | — |
| 0 (this device) | K072634 | Emg Triton -Comp,Model NCA01-XXX Series | Emg Technology Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K781213 | Compressor, Air, Mini-SilentSummary page 1…cation Code : BTI Device Class: 11 3. Information of the 510(k) Cleared Device(Predicate Device): 1) Compressors, Air, Mini-Silent (Model BA-400A), 510(k) Number: K#781213 2) Maxi Compressor (Model 501), 510(k) Number: K#900686 3) DeVilbiss Heavy-Duty Compressor (Model 8650D)/ 510(k) Number:… | 1978 |
| * | K900686 | Maxi CompressorsSummary page 1…e 510(k) Cleared Device(Predicate Device): 1) Compressors, Air, Mini-Silent (Model BA-400A), 510(k) Number: K#781213 2) Maxi Compressor (Model 501), 510(k) Number: K#900686 3) DeVilbiss Heavy-Duty Compressor (Model 8650D)/ 510(k) Number: K#963349 Page I o… | 1990 |
| * | K963349 | Devilbiss 8650DSummary page 1…del BA-400A), 510(k) Number: K#781213 2) Maxi Compressor (Model 501), 510(k) Number: K#900686 3) DeVilbiss Heavy-Duty Compressor (Model 8650D)/ 510(k) Number: K#963349 Page I of 4 4. Device description: The EMG TRITON-COMP. Is a compressor d… | 1997 |
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.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All BTI devicesBTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 device is a portable air compressor intended to provide compressed air for
medical purposes.
It is used with a pneumatic nebulizer to administer humidified air or medication to
the patient.
The device is intended for use on adult and pediatric patients in a home health
care or institutional environment. It's not approved for use with ventilators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072634: Emg Triton -Comp,Model NCA01-XXX Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072634
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026