Product code HET: 510(k) clearances and predicates
Product code HET covers SIRIUS Endoscope System (PR-SI-1230). FDA lists 338 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
338 clearances on file under product code HET. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 2 |
| 2026 so far | 0 |
Recent clearances
Newest HET clearances in the FDA index, with applicant and decision date:
- K250939, SIRIUS Endoscope System (PR-SI-1230), applicant Precision Robotics (Hong Kong) Limited, decided 2025-08-29. FDA record
- K243821, i-Cut, applicant A.M.I. Agency For Medical Innovations GmbH, decided 2025-04-25. FDA record
- K221642, SIRIUS Endoscope System, applicant Precision Robotics (Hong Kong) Limited, decided 2022-12-12. FDA record
- K210116, Video Endoscopy System, 3D Video Endoscopy System, applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., decided 2021-10-13. FDA record
- K201832, Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5, applicant Olympus Medical Systems Corp., decided 2021-09-17. FDA record
- K210104, SurroundScope System, applicant 270surgical , Ltd., decided 2021-07-08. FDA record
- K201617, TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)), applicant Schoelly Fiberoptic GmbH, decided 2021-03-12. FDA record
- K200216, 4K UHD Camera System, applicant Scivita Medical Technology Co., Ltd., decided 2020-08-21. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include i-Cut, SIRIUS Endoscope System. Watch new HET clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code HET?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HET clearances include SIRIUS Endoscope System (PR-SI-1230).
How many 510(k) clearances use product code HET?
338 at the time this page was generated, from openFDA records.
How do I find a predicate device under HET?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new HET clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.