K981575 is the FDA 510(k) clearance record for TYMPANOSTOMY TUBE, a class II device, cleared for Grace Medical, Inc. on 1998-07-15 under FDA product code ETD (Tube, Tympanostomy). FDA records list 21 510(k) clearances for Grace Medical, Inc., from 1988-08-22 to 2023-11-24 . As of 2026-09-10 , FDA records show no recalls naming K981575.
Clearance record Decision date 1998-07-15 Received 1998-05-04 (72 days to decision) Product code ETD Tube, TympanostomyRegulation 21 CFR 874.3880 Device class Class II Review panel Ear, Nose, Throat Applicant Grace Medical, Inc. 7715 Hwy. 70, Suite 109, Bartlett TN 510(k) summary Statement Third party review No
Clearances, product code ETD Trailing 12 months 1 clearance under product code ETD in the twelve months to October 2026, April 2026 the highest month at 1. Show the numbers FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
Product code ETD
Z-0970-2025 Class II Lack of 510(k) clearance. Adept Medical Ltd / initiated 2024-11-24 / 4,080 units (1510 US, 2570 OUS) Z-0969-2025 Class II Lack of 510(k) clearance. Adept Medical Ltd / initiated 2024-11-24 / 2,440 units (1940 US, 500 OUS) Z-0968-2025 Class II Lack of 510(k) clearance. Adept Medical Ltd / initiated 2024-11-24 / 310 units (160 US, 150 OUS) Z-0967-2025 Class II Lack of 510(k) clearance. Adept Medical Ltd / initiated 2024-11-24 / 5,120 units (2190 US, 2930 OUS) Z-0966-2025 Class II Lack of 510(k) clearance. Adept Medical Ltd / initiated 2024-11-24 / 6,280 units (2500 US, 3780 OUS) Z-0965-2025 Class II Lack of 510(k) clearance. Adept Medical Ltd / initiated 2024-11-24 / 2,610 units (240 US, 2370 OUS)
MDM coverage of this record lists here, newest first.
About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
