510(k) Report

510(k) · Cleared

Cleared

Bird 6500 Air Compressor

K864547510(k) TraditionalCleared Jan 12, 198754-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

Bird Products Corp. · BTI Compressor, Air, Portable

Cleared on Jan 12, 1987 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 12, 1987
Review
54 days
Class
Class II
Product code
BTI
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2006: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK864547 Bird 6500 Air CompressorBird Products Corp. · 1987
  2. Descendant · cites it directly · 2 of its ownK041406 Newport C250 Air Compressor Model C250Newport Medical Instruments · 2004
  3. Descendant · 2 generations on · 1 of its ownK060781 Medical Compressor, Models DK50 D and DMEkom S.R.O. · 2006
  4. Descendant · 2 generations on · 0 of its ownK091871 DK50 DSEkom S.R.O. · 2009

Most influential descendants

Showing 3 of 3 · See all
  • K041406Newport C250 Air Compressor Model C250Newport Medical Instruments · 2004 · cites it directly2descendants
  • K060781Medical Compressor, Models DK50 D and DMEkom S.R.O. · 2006 · 2 generations on1descendant
  • K091871DK50 DSEkom S.R.O. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864547Bird 6500 Air CompressorBird Products Corp.1987—
+1K041406Newport C250 Air Compressor Model C250Newport Medical Instruments2004—
+2K060781Medical Compressor, Models DK50 D and DMEkom S.R.O.2006—
+2K091871DK50 DSEkom S.R.O.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200910
FIG. 1 — Lineage of K864547, 1987–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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?

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

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K041406Newport C250 Air Compressor Model C250Newport Medical Instruments20042

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, K041406 (Newport Medical Instruments, 2004) has gone furthest, with 2 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 Bird Products Corp.

35 FDA decisions under this applicant name. See the company

  • K032451Bird Tbird Vela VentilatorBird Products Corp. · 20041 recall
  • K022674Bird Avea VentilatorBird Products Corp. · 20025 recalls
  • K013642AVEABird Products Corp. · 200213 Class I recalls
  • K020730Orion Nasal Cpap SystemBird Products Corp. · 2002
  • K020746Bird Tbird Vela VentilatorBird Products Corp. · 2002

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/K864547 · printed Nov 5, 2026

Cite this page

510(k) Report. “K864547: Bird 6500 Air Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K864547

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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