Trach-Collar
FDA 510(k) K782002 · Kinetic Concepts, Inc.
510(k) numberK782002
Submission
- Device name
- Trach-Collar
- Applicant
- Kinetic Concepts, Inc.
Mchenry, IL, US - Received
- December 4, 1978
- Decision date
- December 15, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EQN – Laryngoscope, Nasopharyngoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
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).
Other 510(k)s with product code EQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/15/2026SE |
| K150248 | ORL Video NasoPharyngo-LarngoscopeEQN · Traditional | Jedmed Instrument Company | 07/23/2015SE |
| K132039 | Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional | Jedmed Instrument Co. | 02/21/2014SE |
| K834172 | Op-Con Surg. Instrument #7EQN · Traditional | Imm Enterprises , Ltd. | 03/06/1984SE |
| K831255 | Laryngoscope Attachment PH2000EQN · Traditional | Eder Instrument Co, Inc. | 09/12/1983SE |
| K830888 | Cool-Lite Fibercoptic Laryngeal ExamEQN · Traditional | National Medical Technology | 04/27/1983SE |
| K822525 | Laryngoscopes RigidEQN · Traditional | Kelleher Corp. | 09/09/1982SE |
| K821710 | Nagashima NX-150F Light Source UnitEQN · Traditional | Kelleher Corp. | 06/25/1982SE |
| K821709 | Nagashima Light Source Unit SL-5EQN · Traditional | Kelleher Corp. | 06/25/1982SE |
| K821708 | Nagashima Light Source Unit SL-4EQN · Traditional | Kelleher Corp. | 06/25/1982SE |
More from Kelleher Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K050261 | V.A.C. Granufoam Silver Protection DressingOMP · Traditional | 05/26/2005SE |
| K041642 | V.A.C. Granufoam Silver DressingOMP · Traditional | 01/25/2005SE |
| K032310 | Mini V.A.C., V.A.C. Freedom, V.A.C. AtsOMP · Traditional | 10/10/2003SE |
| K022011 | V.A.C. Abdominal DressingFTL · Traditional | 02/26/2003SE |
| K021500 | Vacuum Assisted ClosureOMP · Traditional | 12/20/2002SE |
| K021501 | V.A.C. Instillamat (Vacuum Assisted Closure InstillamatOMP · Traditional | 12/02/2002SE |
| K020781 | Wet ChamberNAD · Traditional | 05/06/2002SE |
| K992448 | V.A.C. PlusOMP · Traditional | 01/18/2000SE |
| K972176 | Home Care Bead BedINX · Traditional | 01/16/1998SE |
| K972549 | SimpulseFNM · Traditional | 11/18/1997SE |
Questions and answers
When was Trach-Collar cleared by the FDA?
Trach-Collar (K782002) received a 510(k) decision of Substantially Equivalent on December 15, 1978, 11 days after the submission was received.
What is the product code of K782002?
The FDA product code is EQN – Laryngoscope, Nasopharyngoscope, a Class II (moderate risk) device regulated under 21 CFR 874.4760.