# K011312: BLKS-303 MK Monoplace Hyperbaric System

- Pathway: 510(k) (Abbreviated)
- Applicant: Khrunichev State Research & Production Space Centr
- Decided: Jul 18, 2001 after 79 days
- Product code: CBF (Chamber, Hyperbaric)
- Device class: 2
- Regulation: 21 CFR 868.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060739: Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307 (2006), 3 descendants of its own
- K072757: Dive and Shallow and Grand Dive (2008), 2 descendants of its own
- K171899: Revitalair 430F (2019), 1 descendant of its own
- K220290: Revitalair 430+ (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K011312
Methodology: https://510kreport.com/methodology