# K971124: TM Micro-Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: May 16, 1997 after 50 days
- Product code: ETD (Tube, Tympanostomy)
- Device class: 2
- Regulation: 21 CFR 874.3880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844061 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844061: Microtek Irrigation System, Microtek Medical, Inc. (1985) Summary page 2.

## Cited in the summary but kept off the family tree
- K820453: The Int-Stopper, Burron Medical Products, Inc. (1982). Our OCR of the scanned summary read K820453, FDA’s number for The Int-Stopper (Burron Medical Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “tympanostomy tubes”. Kept off the family tree. Summary page 2.
- K810461: Burron Central Vein Catherization Kit, Burron Medical Products, Inc. (1981). Our OCR of the scanned summary read K810461, FDA’s number for Burron Central Vein Catherization Kit (Burron Medical Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “butterfly catheters”. Kept off the family tree. Summary page 2.

## Indications for use
The TM Micro-Catheter w/ Flange is intended for use as a temporary (less than 29 days) indwelling catheter for delivery of fluids in the treatment of patients with ear disorders. The TM Micro-Catheter w/o Flange is indicated for the immediate (up to 4 hours) delivery of fluids into the middle ear in treating ear disorders.

Source page: https://510kreport.com/device/K971124
Methodology: https://510kreport.com/methodology