510(k) Report

510(k) · Cleared

Cleared

Arcadia Medical Silicone Wire Reinforced Endotracheal Tubes

K060094510(k) TraditionalCleared May 8, 2006116-day reviewClass II21 CFR 868.5730

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

Arcadia Medical Corporation · BTR Tube, Tracheal (W/Wo Connector)

Cleared on May 8, 2006 as substantially equivalent to K792035 (Bivona Medical Technologies, 1979) and 4 other predicates after a 116-day review. Its family tree reaches back 1 generation to 1979.

Decided
May 8, 2006
Review
116 days
Class
Class II
Product code
BTR
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K792035 (1979). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1995: 2 other ancestors1983: 1 other ancestorK792035 · Fome-Cuf-Wire RE-Enforced, Aire-Cuf Wire · Bivona Medical Technologies · 1979 · recalled1975198019851990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors K792035 · Fome-Cuf-Wire RE-Enforced, Aire-Cuf Wire · Bivona Medical Technologies · 1979 · recalled0
  1. Root · 1 generation backK792035 Fome-Cuf-Wire RE-Enforced, Aire-Cuf WireBivona Medical Technologies · 1979 · Recalled
  2. This deviceK060094 Arcadia Medical Silicone Wire Reinforced Endotracheal TubesArcadia Medical Corporation · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792035Fome-Cuf-Wire RE-Enforced, Aire-Cuf WireBivona Medical Technologies19792
0 (this device)K060094Arcadia Medical Silicone Wire Reinforced Endotracheal TubesArcadia Medical Corporation2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199520
200010
FIG. 1 — Lineage of K060094, 1979–2006Source: 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 BTR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BTR device

  1. #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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
*K792035Fome-Cuf-Wire RE-Enforced, Aire-Cuf Wire
Summary page 1
…fication Number: BTR Regulation Number: 868.5730 Panel: Anesthesiology Legally Marketed Predicate Devices: K792035- Fome-Cuf-Wire Reinforced, Aire-Cuf Wire Reinforced Tracheal Tube: Bivona Medical Technologies K830352- Reinforced Si…
Bivona Medical Technologies19792
*K830352Reinforced Silicone Tracheal Tube
Summary page 1
…Anesthesiology Legally Marketed Predicate Devices: K792035- Fome-Cuf-Wire Reinforced, Aire-Cuf Wire Reinforced Tracheal Tube: Bivona Medical Technologies K830352- Reinforced Silicone Tracheal Tube: Portex K954750- Pediatric Wire Reinforced Silicone Endotracheal Tube: Unomedical (Euromedica…
Portex, Inc.1983—
*K954750Pediatric Wire Reinforced Silicone Endotracheal Tube
Summary page 1
…K792035- Fome-Cuf-Wire Reinforced, Aire-Cuf Wire Reinforced Tracheal Tube: Bivona Medical Technologies K830352- Reinforced Silicone Tracheal Tube: Portex K954750- Pediatric Wire Reinforced Silicone Endotracheal Tube: Unomedical (Euromedical) Sdn Bhd 'K954754- Wire Reinforced Silic…
Unomedical Sdn Bhd1995—
*K954754Wire Reinforced Silicone Endotracheal Tube
Summary page 1
…hnologies K830352- Reinforced Silicone Tracheal Tube: Portex K954750- Pediatric Wire Reinforced Silicone Endotracheal Tube: Unomedical (Euromedical) Sdn Bhd 'K954754- Wire Reinforced Silicone Endotracheal Tube: Unomedical (Euromedical) Sdn Bhd K99 1580- LLM Endotracheal Tube: Laryngeal Mask Com…
Unomedical Sdn Bhd1995—
*K991580Ilm Endotracheal Tube
Summary page 1
…Reinforced Silicone Endotracheal Tube: Unomedical (Euromedical) Sdn Bhd 'K954754- Wire Reinforced Silicone Endotracheal Tube: Unomedical (Euromedical) Sdn Bhd K99 1580- LLM Endotracheal Tube: Laryngeal Mask Company, Ltd. 510(K) SUMMARY…
The Laryngeal Mask Co., Ltd.2000—

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?

  • 1 of the 5 ancestors has a recall of any class.

How does its category compare?

All BTR devices

BTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTR

7in 2025

2007: 12008: 72009: 72010: 32011: 22012: 52013: 12014: 32015: 32016: 12017: 22018: 52019: 52020: 32021: 12022: 12023: 12024: 12025: 72026 (partial year): 2
2007high 7 (2008) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTR

258in 2025

2008: 61 days median2009: 135 days median2010: 179 days median2012: 261 days median2014: 308 days median2015: 262 days median2018: 242 days median2019: 211 days median2020: 246 days median2025: 258 days median
2007high 308 (2014) · low 61 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BTR

3in 2022

2007: 22009: 212014: 20, 19 Class I2016: 12020: 1, 1 Class I2021: 22022: 32026 (partial year): 1
2007high 21 (2009) · low 0 (2008)2026

Class I (20 since 2007) Class II/III not classified

Adverse event reports per year · BTR

1,799in 2025

2007: 1362008: 1692009: 1552010: 3352011: 4222012: 5112013: 8072014: 9852015: 1,0162016: 8362017: 8122018: 9772019: 1,3792020: 1,0702021: 1,3292022: 1,1322023: 1,3302024: 1,6782025: 1,799
2007high 1,799 (2025) · low 136 (2007)2025

MAUDE reports naming product code BTR, 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
20071—2136
20087610169
2009713521155
201031790335
20112—0422
201252610511
20131—0807
2014330820 (19)985
2015326201,016
20161—1836
20172—0812
201852420977
2019521101,379
202032461 (1)1,070
20211—21,329
20221—31,132
20231—01,330
20241—01,678
2025725801,799
20262—1—

What is it indicated for?

Endotracheal Tubes are indicated for use in providing airway management by oral intubation of the trachea during anesthesia and during ventilator support of respiration. Wire Reinforced Endotracheal Tubes are indicated for use in procedures requiring flexing of the neck or movement of the patient (lateral or prone position).

Indications for use as stated in the FDA summary.

More from Arcadia Medical Corporation

2 FDA decisions under this applicant name. See the company

  • K031553Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy TubesArcadia Medical Corporation · 20032 recalls

Recent decisions in BTR

The BTR category page

  • K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2026
  • K253437Spiro-VISTASpiro Robotics · 2026
  • K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless…Covidien, LLC · 2025
  • K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube…Covidien, LLC · 2025
  • K243579AeroJet Ventilation CatheterPipeline Medical Products, LLC · 2025

https://510kreport.com/device/K060094 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060094: Arcadia Medical Silicone Wire Reinforced Endotracheal Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060094

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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