Product code IPF: 510(k) clearances and predicates
Product code IPF covers Apollo Quattro (APQ-10M). FDA lists 548 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
548 clearances on file under product code IPF. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 7 |
| 2023 | 9 |
| 2024 | 7 |
| 2025 | 3 |
| 2026 so far | 3 |
Recent clearances
Newest IPF clearances in the FDA index, with applicant and decision date:
- K253542, Apollo Quattro (APQ-10M), applicant Weero Co., Ltd., decided 2026-06-08. FDA record
- K252816, High Tone Power therapy (HiToP) (Model: HiToP PNP), applicant Mohammadali Nezakati, decided 2026-06-02. FDA record
- K260142, StimelMD (SSMD) system, applicant Motion Informatics ltd., decided 2026-05-27. FDA record
- K251083, Compact II, applicant Enraf-Nonius, B.V., decided 2025-09-12. FDA record
- K241433, EVE Synergy (EVE-20M), applicant Weero Co., Ltd., decided 2025-06-04. FDA record
- K241488, TrainFES Advance, applicant Trainfes, decided 2025-02-05. FDA record
- K240348, Quantum Mitohormesis (QMT) (M2101), applicant Quantumtx Pte. , Ltd., decided 2024-12-19. FDA record
- K240992, eMVFit (MVF-10M), applicant Weero Co., Ltd., decided 2024-10-10. 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 High Tone Power therapy (HiToP) (Model: HiToP PNP), StimelMD (SSMD) system. Watch new IPF 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 IPF?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent IPF clearances include Apollo Quattro (APQ-10M).
How many 510(k) clearances use product code IPF?
548 at the time this page was generated, from openFDA records.
How do I find a predicate device under IPF?
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 IPF clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.