# Emblation, Ltd.

- Location (FDA's records): Alloa, GB
- FDA decisions: 4 (2018–2025): 4 510(k) clearances
- Names in FDA's records: Emblation , Ltd. (2); Emblation Limited (2)
- Product codes: NEY (4)
- 510(k) review time since 2016: median 90 days, against 94 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 4 (4 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
- Foundry Newco X, Inc.: 1 (https://510kreport.com/company/foundry-newco-x)
- Miramar Labs, Inc.: 1 (https://510kreport.com/company/miramar-labs)
- Covidien: 1 (https://510kreport.com/company/covidien)

## Its most-cited devices
- K181941: Swift System (2018), cited by 2
- K222388: swiftPro System (2023), cited by 1
- K240518: swiftPro™ System (2024), cited by 1

## Recent decisions
- K250718: swiftPro System (SWF-SPS); Swift System (SWF-SYS) (Aug 8, 2025)
- K240518: swiftPro™ System (Apr 23, 2024)
- K222388: swiftPro System (May 4, 2023)
- K181941: Swift System (Oct 18, 2018)

Source page: https://510kreport.com/company/emblation