# K822112: Ophthalmic Knife

- Pathway: 510(k) (Traditional)
- Applicant: Sharpoint, Inc.
- Decided: Aug 10, 1982 after 22 days
- Product code: HNN (Knife, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.4350
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 1 cites it directly.
0 of 32 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
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K113151: Ifs Laser System (2012), 19 descendants of its own
- K120732: Lenssx Laser System (2012), 12 descendants of its own
- K141476: Wavelight FS200 Laser System (2014), 8 descendants of its own
- K120426: Victus Laser Platform (2012), 7 descendants of its own

## Recalls of this device
- Mar 3, 2004 · Not classified · Z-0947-04: Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
- Mar 3, 2004 · Not classified · Z-0948-04: Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
- Mar 3, 2004 · Not classified · Z-0949-04: Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
- Mar 3, 2004 · Not classified · Z-0946-04: Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
- Mar 3, 2004 · Not classified · Z-0950-04: Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
- Mar 3, 2004 · Not classified · Z-0945-04: Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
- Aug 21, 2003 · Not classified · Z-0026-04: text on product handle is incorrect
- May 7, 2003 · Not classified · Z-0918-03: Incorrect handle was used in the manufacture of product 52-2761
- Jan 7, 2003 · Not classified · Z-0705-03: size mislabeled on product handle

Source page: https://510kreport.com/device/K822112
Methodology: https://510kreport.com/methodology