# K982465: Deroyal Industries, Inc. Defogger

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Aug 11, 1998 after 27 days
- Product code: OCT (Anti Fog Solution And Accessories, Endoscopy)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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.
24 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Struckmeyer: named in the summary without a submission number
- (no number) O.R. Concepts: named in the summary without a submission number
- (no number) Inman Medical Corporation: named in the summary without a submission number
- (no number) Dexide: named in the summary without a submission number
- (no number) Eagle Medical International: named in the summary without a submission number

## Most influential descendants
- K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp) (2006), 23 descendants of its own
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 (2008), 16 descendants of its own
- K151117: Laparoscope Lens Shield Device (2015), 8 descendants of its own
- K160172: Laparoscope Lens Shield Device (2016), 7 descendants of its own
- K170103: Laparoscope Lens Shield Device (LENS) (2017), 6 descendants of its own

## Recalls of this device
- May 30, 2019 · Class II · Z-1984-2019: The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.

## Indications for use
The DeRoyal Industries, Inc. DeFogger is indicated for use during endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endoscope device, to prevent fogging of the endoscope lens.

Source page: https://510kreport.com/device/K982465
Methodology: https://510kreport.com/methodology