FDA product code KTR: Tube, Aspirating, Bronchoscope, Rigid
KTR is the FDA product code for tube, aspirating, bronchoscope, rigid. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under KTR, from 3 different applicants. The average 510(k) review took 120 days (median 38).
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Tube, Aspirating, Bronchoscope, Rigid |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KTR clearance
Top KTR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sherwood Medical Co. | 2 | 1982-04-09 |
| Ballard Medical Products | 1 | 1993-07-30 |
| Kelleher Corp. | 1 | 1982-08-25 |
Most recent KTR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923487 | Ballard Medical Products | BAL CATH | 1993-07-30 | 380 |
| K822255 | Kelleher Corp. | RIGID SUCTION TIPS | 1982-08-25 | 27 |
| K820572 | Sherwood Medical Co. | ARGYLE DELEE SUCTION CATHETER W/MUCOUS | 1982-04-09 | 38 |
| K791327 | Sherwood Medical Co. | ARGYLE TAUSSIG CULTURE CATHETER | 1979-08-22 | 37 |
Recalls for KTR devices
openFDA lists no recalls for product code KTR.
Frequently asked questions
What is FDA product code KTR?
KTR is the FDA product code for tube, aspirating, bronchoscope, rigid. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is KTR?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTR?
Across 4 cleared submissions the average was 120 days from receipt to decision (median 38).
Which companies have the most KTR clearances?
Sherwood Medical Co. (2); Ballard Medical Products (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTR
- Run a recall and safety report across every KTR manufacturer
- Watch product code KTR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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