510(k) Report

510(k) · Cleared

Cleared

Medport Emergency Medication Airway Tube Adapter

K971759510(k) TraditionalCleared Mar 2, 1998294-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

Green Field Medical Sourcing, Inc. · BTR Tube, Tracheal (W/Wo Connector)

Cleared on Mar 2, 1998 after a 294-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Mar 2, 1998
Review
294 days
Class
Class II
Product code
BTR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared1995200020052010201520202025
  1. This deviceK971759 Medport Emergency Medication Airway Tube AdapterGreen Field Medical Sourcing, Inc. · 1998
  2. Descendant · cites it directly · 0 of its ownK021044 MadettWolfe Tory Medical, Inc. · 2002 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K021044MadettWolfe Tory Medical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971759Medport Emergency Medication Airway Tube AdapterGreen Field Medical Sourcing, Inc.1998—
+1K021044MadettWolfe Tory Medical, Inc.20028

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K971759, 1998–2002Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K021044MadettWolfe Tory Medical, Inc.20020

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, K021044 (Wolfe Tory Medical, Inc., 2002) has gone furthest, with 0 descendants of its own.

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?

1. To establish 2 path in which to inject medication into the lungs of a patient who has undergone cardiac and/or pulmonary arrest and who is being ventilated through an intubated airway.

2. To establish a means in which to introduced medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient.

3. To provide an alternative means other than intravenous injection for administering life-saving drugs when a patient is being assisted by an endotracheal tube.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K971759: Medport Emergency Medication Airway Tube Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971759

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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