Product code IOR: 510(k) clearances and predicates
Product code IOR covers ErgoSteel (ES0001/696). FDA lists 468 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
468 clearances on file under product code IOR. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 9 |
| 2024 | 4 |
| 2025 | 7 |
| 2026 so far | 17 |
Recent clearances
Newest IOR clearances in the FDA index, with applicant and decision date:
- K253762, ErgoSteel (ES0001/696), applicant Strongback Mobility AG C/O Blueaudit GmbH, decided 2026-09-22. FDA record
- K261919, Multifunctional wheelchair (YJ-059), applicant Zhenjiang Assure Medical Equipment Co., Ltd., decided 2026-09-16. FDA record
- K260141, Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C), applicant Zhenjiang Assure Medical Equipment Co., Ltd., decided 2026-09-15. FDA record
- K260144, Reclining wheelchair (YJ-013L), applicant Zhenjiang Assure Medical Equipment Co., Ltd., decided 2026-09-15. FDA record
- K260145, YJ-K1K2 Wheelchair (YJ-013F), applicant Zhenjiang Assure Medical Equipment Co., Ltd., decided 2026-09-15. FDA record
- K261571, Manual Wheelchair (H008, PCK7), applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., decided 2026-08-06. FDA record
- K252370, GEN 4 JOY Wheelchair, applicant Free Wheelchair Mission, decided 2026-07-24. FDA record
- K261076, Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02), applicant GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd., decided 2026-06-22. 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 Multifunctional wheelchair (YJ-059), Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C). Watch new IOR 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 IOR?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent IOR clearances include ErgoSteel (ES0001/696).
How many 510(k) clearances use product code IOR?
468 at the time this page was generated, from openFDA records.
How do I find a predicate device under IOR?
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 IOR clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.