# Claritas Healthtech Pte, Ltd.

- Location (FDA's records): Singapore, SG
- FDA decisions: 3 (2021–2025): 3 510(k) clearances
- Product codes: LLZ (3)
- 510(k) review time since 2016: median 86 days, against 116 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zetta Medical Technologies, LLC: 1 (https://510kreport.com/company/zetta-medical-technologies)
- Subtle Medical, Inc.: 1 (https://510kreport.com/company/subtle-medical)

## Firms that cite its devices most
- Subtle Medical, Inc.: 1 (https://510kreport.com/company/subtle-medical)

## Its most-cited devices
- K213140: Claritas iPET (2021), cited by 2

## Recent decisions
- K244016: iPETcertum (v1.0) (Aug 5, 2025)
- K213140: Claritas iPET (Dec 22, 2021)
- K212470: iRAD (Oct 20, 2021)

Source page: https://510kreport.com/company/claritas-healthtech