510(k) Report

510(k) · Cleared

Cleared

San UP S.a. Nebulizer Compressor, with Disposable Nebulizer, Model 3050

K002468510(k) TraditionalCleared Mar 2, 2001203-day reviewClass II21 CFR 868.6250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

San UP S.A. · BTI Compressor, Air, Portable

Cleared on Mar 2, 2001 after a 203-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 2, 2001
Review
203 days
Class
Class II
Product code
BTI
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared200020052010201520202025
  1. This deviceK002468 San UP S.a. Nebulizer Compressor, with Disposable Nebulizer, Model…San UP S.A. · 2001
  2. Descendant · cites it directly · 0 of its ownK092859 Merits Model N Series Nebulizer CompressorsMerits Health Products Co., Ltd. · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K092859Merits Model N Series Nebulizer CompressorsMerits Health Products Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002468San UP S.a. Nebulizer Compressor, with Disposable Nebulizer, Model 3050San UP S.A.2001—
+1K092859Merits Model N Series Nebulizer CompressorsMerits Health Products Co., Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K002468, 2001–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092859Merits Model N Series Nebulizer CompressorsMerits Health Products Co., Ltd.20100

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?

  • Of its descendants, K092859 (Merits Health Products Co., Ltd., 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BTI devices

BTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTI

1in 2013

2008: 12009: 12012: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

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

2007: 12013: 12023: 3, 3 Class I
2007high 3 (2023) · low 0 (2008)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · BTI

120in 2025

2007: 182008: 92009: 72010: 112011: 132012: 2172013: 1,7102014: 9822015: 2942016: 1392017: 1032018: 712019: 1142020: 1112021: 2782022: 2482023: 3252024: 1662025: 120
2007high 1,710 (2013) · low 7 (2009)2025

MAUDE reports naming product code BTI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—118
20081—09
20091—07
20100—011
20110—013
20121—0217
20131—11,710
20140—0982
20150—0294
20160—0139
20170—0103
20180—071
20190—0114
20200—0111
20210—0278
20220—0248
20230—3 (3)325
20240—0166
20250—0120
20260—0—

More from San UP S.A.

2 FDA decisions under this applicant name. See the company

  • K002543Comoact Ultrasonic Nebulizer, Model 3060San UP S.A. · 2001

Recent decisions in BTI

The BTI category page

  • K131881Ombra Table Top CompressorTrudell Medical Intl. · 2013
  • K113338Medical Air CompressorOricare, Inc. · 2012
  • K091871DK50 DSEkom S.R.O. · 2009
  • K072634Emg Triton -Comp,Model NCA01-XXX SeriesEmg Technology Co., Ltd. · 2008
  • K060781Medical Compressor, Models DK50 D and DMEkom S.R.O. · 2006

https://510kreport.com/device/K002468 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002468: San UP S.a. Nebulizer Compressor, with Disposable Nebulizer, Model 3050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002468

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026