510(k) Report

510(k) · Cleared

Recalled · Class I · 2023

Slick Set

K780900510(k) TraditionalCleared Jul 17, 197863-day reviewClass II21 CFR 868.5730Recalls 28 (26 Class I)

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

Polamedco, Inc. · BTR Tube, Tracheal (W/Wo Connector)

Cleared on Jul 17, 1978 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has a Class I recall. It has been recalled 28 times, including 26 Class I recalls.

Decided
Jul 17, 1978
Review
63 days
Class
Class II
Product code
BTR
Recalls
28 (26 Class I)
Predicates
0

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

FIG. 1 — Lineage of K780900Source: FDA 510(k) database · 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.

1 device in this family has a Class I recall. 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 12.5 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 25, 2023Class IZ-1841-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1829-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1843-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1842-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1901-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1904-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1837-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1840-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1905-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1897-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1836-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1838-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1902-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1832-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1831-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1830-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1834-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1839-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1835-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1903-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1827-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1844-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1900-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1860-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1833-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
May 25, 2023Class IZ-1828-2023Under Investigation by firmReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Dec 8, 2022Class IIZ-1010-2023Process controlPotential for pilot balloon non-inflation or cuff non-deflation.
Jul 16, 2021Class IIZ-2319-2021Process controlThe firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

The 5 latest of 28 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

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—

More from Polamedco, Inc.

20 FDA decisions under this applicant name. See the company

  • K983000Cricothyrotomy TubePolamedco, Inc. · 1999
  • K954383Sureloc Circuit ConnectorPolamedco, Inc. · 1995
  • K953793IntroscopePolamedco, Inc. · 1995
  • K950713Airguide StylettePolamedco, Inc. · 1995
  • K933596Gastric, Catheter, Irrigation & AspirationPolamedco, Inc. · 1995

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/K780900 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780900: Slick Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780900

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