US · FDA CP 7382.850 · Active Feb 2026 | EU · AI Act Article 50 · Deadline Aug 2, 2026 | EU · Battery Regulation 2023/1542 · DPP Feb 2027 | SA · PDPL · Active Mar 2025 | AU · TGA AI Guidance · Active 2025 | JP · PMDA AI Roadmap · 2026 | KR · MFDS AI Framework · 2026 | US · FDA CP 7382.850 · Active Feb 2026 | EU · AI Act Article 50 · Deadline Aug 2, 2026 | EU · Battery Regulation 2023/1542 · DPP Feb 2027 | SA · PDPL · Active Mar 2025 | AU · TGA AI Guidance · Active 2025 | JP · PMDA AI Roadmap · 2026 | KR · MFDS AI Framework · 2026 |
Patent Pending · Sustwinability LLC · Woodinville, WA

Not a governance platform.
The physics layer.

P→D Bridge  ·  ALCOA+ SHA-256  ·  HITL Gate  ·  Zero Egress

You are personally liable for what your AI does on the floor — even without direct knowledge of the violation.
United States v. Park, 1975  ·  Now extended to AI-influenced production decisions under FDA CP 7382.850  ·  Read more →
Kaelox Launch
00Days
:
00Hrs
:
00Min
:
00Sec
22 · June · 2026
EU AI Act · Art. 50
Machine-readable marking
00Days
:
00Hrs
:
00Min
:
00Sec
Deadline · 2 · Aug · 2026
Governance Gap Calculator
How many AI systems are currently influencing production decisions at your facility?
AI systems
Estimated annual governance gap exposure
Estimated from FDA 483 response costs ($100K–$500K per observation), Class II recall exposure ($1M–$5M), and COPQ benchmarks for undocumented AI-influenced production decisions. Individual exposure varies by facility, sector, and AI deployment maturity. Not legal or financial advice.
Real Data Validation · Phase 0 Evidence
100%Recall — zero production failures missed
0%False Negative Rate — primary regulatory KPI
93.4%Precision
6,227SHA-256 chain records verified
UCI SECOM Semiconductor Dataset · 1,567 production runs · Ground truth validated · Full methodology available
✓ Report sent. Check your inbox.
Get notified at launch
✓ You are on the list.

Your email is used only to notify you at launch and send requested materials. We do not share it.  ·  Sustwinability LLC  ·  Woodinville, WA  ·  info@kaelox.ai

inAjay Batra inKaelox
© 2026 Sustwinability LLC Patent Pending · 32 Claims Zero Data Egress ALCOA+ SHA-256 Woodinville, WA