# K830332: Budde-Halo Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Ohio Medical Instrument Co., Inc.
- Decided: Mar 2, 1983 after 29 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 4 cite it directly.
1 of 17 devices in its family (counting itself) has 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
- K060973: Vycor Surgical Access Systems (2006), 10 descendants of its own
- K120691: Brain Port (2012), 8 descendants of its own
- K182211: Aurora Surgiscope System (2019), 4 descendants of its own
- K191861: Aurora Surgiscope System (2019), 3 descendants of its own
- K060097: Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00 (2006), 3 descendants of its own

## Recalls of this device
- Feb 26, 2003 · Not classified · Z-0781-03: The component was manufactured with an insufficient weld that could break during use.

Source page: https://510kreport.com/device/K830332
Methodology: https://510kreport.com/methodology