510(k) · Cleared
ClearedDisposable Endotracheal tube, sterile, AccuCuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Medis Medical Device Co., Ltd. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Apr 7, 2017 as substantially equivalent to K042683 (Well Lead Medical Instruments, 2005) and 3 other predicates after a 389-day review. Its family tree reaches back 8 generations to 1990. 7 of the 37 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Apr 7, 2017
- Review
- 389 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K903730 (1990). 35 ancestors in all, the oldest K811033 (1981). 1 later device descends from it, 1 citing it directly. 7 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 7 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 6 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 5 generations backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- 4 generations backK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- 3 generations backK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
- 2 generations backK130304 Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
- 1 generation backK142103 Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015
- This deviceK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
Class I recalls in this family
- K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal…2 generations back · 2000
- K961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy2 generations back · 1996
- K961840 Rusch Oral/Nasal Tracheal Tube, Plain…2 generations back · 1996
- K931163 Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye2 generations back · 1993
Most influential descendants
Showing 1 of 1 · See all- K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −7 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −6 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −5 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| −4 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| −3 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
| −2 | K130304 | Lma Family of Airways | The Laryngeal Mask Co., Ltd. | 2014 | — |
| −1 | K142103 | Cuff Pilot, Sure Seal | Teleflexmedical, Inc. | 2015 | — |
| 0 (this device) | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
| +1 | K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 4 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 2 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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.
7 devices in this family have 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 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042683 | Well Lead Endotracheal TubeSummary page 5…5 === 510(k) Premarket Notification Submission K160694 III. PREDICATE DEVICES Endotracheal Tubes Well Lead Endotracheal Tube (K042683) Well Lead Reinforced Endotracheal Tube( K073383) TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)( K041311) Inflatable Trac… | 2005 |
| * | K073383 | Well Lead Reinforced Endotracheal TubeSummary page 5…k) Premarket Notification Submission K160694 III. PREDICATE DEVICES Endotracheal Tubes Well Lead Endotracheal Tube (K042683) Well Lead Reinforced Endotracheal Tube( K073383) TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)( K041311) Inflatable Tracheal Tube Cuff Cuff PilotTM (K142103) This pred… | 2008 |
| * | K041311 | Tiger Endotracheal Tubes (Various Models and Sizes)Summary page 5…E DEVICES Endotracheal Tubes Well Lead Endotracheal Tube (K042683) Well Lead Reinforced Endotracheal Tube( K073383) TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)( K041311) Inflatable Tracheal Tube Cuff Cuff PilotTM (K142103) This predicate has not been subject to a design‐related recall. No refe… | 2005 |
| * | K142103 | Cuff Pilot, Sure SealSummary page 5…be (K042683) Well Lead Reinforced Endotracheal Tube( K073383) TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)( K041311) Inflatable Tracheal Tube Cuff Cuff PilotTM (K142103) This predicate has not been subject to a design‐related recall. No reference devices were used in this submission. IV. DE… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190274 | Endotracheal Tube | 2019 | 0 |
Has anything in its family been recalled? (7 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993786Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphyRusch Intl. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 13 Class I recalls
- K961837Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 132 Class I recalls
- K961840Rusch Oral/Nasal Tracheal Tube, Plain Magill/MurphyRusch Intl. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 124 Class I recalls
- K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993 · 2 generations back · ◆ in the 1993 ancestors bar of FIG. 112 Class I recalls
- K931164Rusch Agt PVC Preform Nasal Trach Tub/Cuf W/Mur EYRusch, Inc. · 1993 · 2 generations back · ◆ in the 1993 ancestors bar of FIG. 110 Class I recalls
- K931165Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur EyeRusch, Inc. · 1993 · 2 generations back · ◆ in the 1993 ancestors bar of FIG. 17 Class I recalls
- K931166Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYRusch, Inc. · 1993 · 2 generations back · ◆ in the 1993 ancestors bar of FIG. 19 Class I recalls
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 11 of the 35 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K190274 (Tianjin Medis Medical Device Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K042683.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Sterile Disposable Endotracheal Tube device is intended for oral or nasal intubation and for airway management.
The Accu-Cuff device is intended to inflate cuffs and to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160694 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160694: Disposable Endotracheal tube, sterile, AccuCuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160694
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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