FDA product code · Anesthesiology
BTRTube, Tracheal (W/Wo Connector)
Product code BTR covers Tube, Tracheal (W/Wo Connector), a Class II device regulated under 21 CFR 868.5730. FDA has cleared 241 devices in this code, 4 of them in the last 12 months. Median review time across the 241 most recent decisions is 87 days. openFDA lists 226 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5730
- Review panel
- Anesthesiology
- Clearances
- 241
What is happening in BTR right now?
BTR (Tube, Tracheal (W/Wo Connector)) has two findings, most consequential first. 2 first-time filers in the last 12 months, Spiro Robotics and Pipeline Medical Products, LLC (K253437, K243579). The code is crowded, scoring 77 of 100 — 119 companies hold a clearance here and 4 arrived in the last 12 months (BTR:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253437, K243579 |
| Crowding | Context | BTR:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in BTR?
FDA has cleared 241 devices under product code BTR since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253437 | Spiro-VISTA | Spiro Robotics | |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) | Covidien, LLC | |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | Covidien, LLC | |
| K243579 | AeroJet Ventilation Catheter | Pipeline Medical Products, LLC | |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) | William Cook Europe Aps | |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | Flexicare Medical Limited. | |
| K242495 | LMA Fastrach ETT SU | Teleflex Medical | |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) | Teleflex Incorporated | |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | Covidien, LLC | |
| K223130 | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) | Covidien |
How long does FDA review take for BTR?
The median FDA review time for BTR is 87 days, measured across the 241 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in BTR?
openFDA lists 226 recall records against product code BTR. A recall record covers one firm's corrective action and may span many device lots.
Z-1289-2025Open, ClassifiedSmiths Medical ASD, Inc.
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
Z-1876-2024Open, ClassifiedMEDLINE INDUSTRIES, LP - Northfield
Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
Z-1827-2023Open, ClassifiedTeleflex, Inc.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1828-2023Open, ClassifiedTeleflex, Inc.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1829-2023Open, ClassifiedTeleflex, Inc.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Showing the 5 most recently initiated of 226. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for BTR?
MAUDE holds 4,919 adverse-event reports naming product code BTR, 1,203 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in BTR unusual?
One month sits above BTR's own expected range: 1 May 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 108 | Insufficient history | No expected range — too little history | |
| 93 | Insufficient history | No expected range — too little history | |
| 130 | Insufficient history | No expected range — too little history | |
| 115 | Insufficient history | No expected range — too little history | |
| 100 | Insufficient history | No expected range — too little history | |
| 146 | Insufficient history | No expected range — too little history | |
| 91 | Insufficient history | No expected range — too little history | |
| 83 | Insufficient history | No expected range — too little history | |
| 104 | Insufficient history | No expected range — too little history | |
| 141 | Insufficient history | No expected range — too little history | |
| 105 | Insufficient history | No expected range — too little history | |
| 125 | Insufficient history | No expected range — too little history | |
| 153 | Insufficient history | No expected range — too little history | |
| 172 | Insufficient history | No expected range — too little history | |
| 131 | Insufficient history | No expected range — too little history | |
| 143 | Insufficient history | No expected range — too little history | |
| 169 | Insufficient history | No expected range — too little history | |
| 182 | Insufficient history | No expected range — too little history | |
| 113 | Insufficient history | No expected range — too little history | |
| 122 | Insufficient history | No expected range — too little history | |
| 122 | Insufficient history | No expected range — too little history | |
| 119 | 75–169 | Within expected (75–169) | |
| 107 | 63–147 | Within expected (63–147) | |
| 127 | 75–163 | Within expected (75–163) | |
| 167 | 80–171 | Within expected (80–171) | |
| 181 | 85–174 | Above expected (85–174) | |
| 147 | 95–205 | Within expected (95–205) | |
| 138 | 147–321 | Below expected (147–321) | |
| 149 | 83–229 | Within expected (83–229) | |
| 148 | 86–238 | Within expected (86–238) | |
| 137 | 85–226 | Within expected (85–226) | |
| 147 | 75–196 | Within expected (75–196) | |
| 189 | 88–220 | Within expected (88–220) | |
| 209 | 114–266 | Within expected (114–266) | |
| 130 | 102–229 | Within expected (102–229) | |
| 137 | 98–242 | Within expected (98–242) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in BTR.
Who has entered BTR in the last year?
2 companies filed in BTR for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Spiro Robotics | K253437 | |
| Pipeline Medical Products, LLC | K243579 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in BTR?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in BTR?
Across the 241 most recent decisions, these applicants filed most often in BTR.
| Applicant | Recent clearances |
|---|---|
| Sheridan Catheter Corp. | 11 |
| Mallinckrodt Critical Care | 10 |
| Rusch, Inc. | 10 |
| Bivona Medical Technologies | 8 |
| Polamedco, Inc. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch BTR
Get an email the morning anything changes in BTR — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.