Product code KWP: 510(k) clearances and predicates
Product code KWP covers SOLSTICE OCT System. FDA lists 430 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
430 clearances on file under product code KWP. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest KWP clearances in the FDA index, with applicant and decision date:
- K143278, LnK Posterior Cervical Fixation System, applicant L&K BIOMED Co., Ltd., decided 2015-07-29. FDA record
- K150753, OASYS System, applicant Stryker Corporation, decided 2015-06-09. FDA record
- K150851, Sure Lok Mini Posterior Cervical/Upper Thoracic System, applicant Precision Spine, Inc., decided 2015-06-04. FDA record
- K142867, Reliance Posterior Cervical-Thoracic System, applicant Reliance Medical Systems, LLC, decided 2015-04-29. FDA record
- K150254, Streamline OCT Occipito-Cervico-Thoracic System, applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), decided 2015-04-28. FDA record
- K142253, SOLSTICE OCT System, applicant Life Spine, Inc., decided 2015-04-23. FDA record
- K150229, SOLSTICE OCT System, applicant Life Spine, Inc., decided 2015-04-07. FDA record
- K143249, SOLSTICE OCT System, applicant Life Spine, Inc., decided 2015-04-07. 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 LnK Posterior Cervical Fixation System, OASYS System. Watch new KWP 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 KWP?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KWP clearances include SOLSTICE OCT System.
How many 510(k) clearances use product code KWP?
430 at the time this page was generated, from openFDA records.
How do I find a predicate device under KWP?
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 KWP clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.