510(k) Report

510(k) · Cleared

Cleared

Minimate Compressor

K051691510(k) TraditionalCleared Dec 9, 2005169-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

Precision Medical, Inc. · BTI Compressor, Air, Portable

Cleared on Dec 9, 2005 as substantially equivalent to K923324 (Precision Medical, Inc., 1993) after a 169-day review. Its family tree reaches back 1 generation to 1993.

Decided
Dec 9, 2005
Review
169 days
Class
Class II
Product code
BTI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K923324 (1993). No later device cites it as a predicate yet.

K923324 · Precision Mist Compressor · Precision Medical, Inc. · 19931990199520002005
K923324 · Precision Mist Compressor · Precision Medical, Inc. · 19930
  1. Root · 1 generation backK923324 Precision Mist CompressorPrecision Medical, Inc. · 1993
  2. This deviceK051691 Minimate CompressorPrecision Medical, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K923324Precision Mist CompressorPrecision Medical, Inc.1993—
0 (this device)K051691Minimate CompressorPrecision Medical, Inc.2005—
FIG. 1 — Lineage of K051691, 1993–2005Source: 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), 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
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K923324Precision Mist Compressor
Summary page 1
…Device Equivalence Precision Medical, Inc. is claiming substantial equivalence to Precision Medical Care Mist compressor/ K923324/A Device Description The compressor is made up of three basic sections I. Electrical motor 2. Compre…
Precision Medical, Inc.1993—

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?

  • Its one ancestor has no recall.

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—

What is it indicated for?

The Precision Medical, Inc. Minimate compressor is intended to provide Compressed air to a small volume nebulizers. .The device is intended to be used at a 50% duty cycle. It is not intended as a life supporting device.

Indications for use as stated in the FDA summary.

More from Precision Medical, Inc.

30 FDA decisions under this applicant name. See the company

  • K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc. · 2018
  • K140179Easy GO VacPrecision Medical, Inc. · 2014
  • K103563Precision Portable Oxygen Concentration Model 4150Precision Medical, Inc. · 2011
  • K103324Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2011
  • K090781HELIO2 BlenderPrecision Medical, Inc. · 2009

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/K051691 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051691: Minimate Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051691

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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