ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH
ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH: 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH. Its amount of 301 is top-decile (96th percentile of 414 records). Dated 44 days ago, it serves as a historical benchmark. Score 61/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 301 · 96th percentile of 414 FDAPulse records · 2.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 6 related CH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K253762 |
| Device | ErgoSteel (ES0001/696) |
| Applicant | Strongback Mobility AG C/O Blueaudit GmbH |
| Specialty / panel | Other |
| Product code | IOR |
| Device class | 1 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-11-25 |
| Decision date | 2026-09-22 |
| Review time (days) | 301 |
| Third-party review | No |
| Applicant location | Pfaeffikon, CH |
| amount percentile | 96th of 414 (median 138, 2.2x median) |
| Peer records CSV (7 CH records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-22
- Data refreshed: 2026-11-04
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Top FDAPulse records (CH first): DRIM-Nail System (K260115) · M-Vizion Femoral Revision System Extension (K260173) · CAS-One IR (K261225) · OTOPLAN (K262080) · GMK Extension (K262057) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH and 7 CH peers
- CH FDAPulse records like this one: 7
- ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH's amount: 96th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CH peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 301-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 44 days ago.
What is the FDAPulse record for ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH?
ErgoSteel (ES0001/696) (K253762) by Strongback Mobility AG C/O Blueaudit GmbH was cleared on 2026-09-22 after 301 days of review.
How does ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH compare to other FDAPulse records?
This is a top-decile record: its amount of 301 is 2.2x the median of 138 across 414 records. It is 44 days old, still within a typical 45-day follow-up window.
ErgoSteel (ES0001/696) (K253762) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| ErgoSteel (ES0001/696) (K253762) | CH | 2026-09-22 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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- BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215): 510(k) cleared for Bd Biosciences
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