# K043494: Mastel Laser Clean Room, Model Ebs-100

- Pathway: 510(k) (Traditional)
- Applicant: Mastel Precision Surgical Instruments, Inc.
- Decided: Oct 4, 2005 after 291 days
- Product code: FYD (Apparatus, Exhaust, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.5070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011462 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011462: Oil for Tissue Culture, Conception Technologies (2001) Summary page 2.
- K030116: Enhance-S Plus H, Conception Technology, Inc. (2003) Summary page 2.
- K030117: Enhance Sperm Freeze, Conception Technology, Inc. (2003) Summary page 2.

## Indications for use
Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching. Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures. SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

Source page: https://510kreport.com/device/K043494
Methodology: https://510kreport.com/methodology