510(k) Report

510(k) · Cleared

Recalled · 2004

Ophthalmic Knife

K822112510(k) TraditionalCleared Aug 10, 198222-day reviewClass I21 CFR 886.4350Recalls 9

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sharpoint, Inc. · HNN Knife, Ophthalmic

Cleared on Aug 10, 1982 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it. It has been recalled 9 times.

Decided
Aug 10, 1982
Review
22 days
Class
Class I
Product code
HNN
Recalls
9
Predicates
0

31 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2014: 3 descendants cleared2012: 5 descendants cleared2013: 2 descendants cleared2016: 1 descendant cleared2015: 5 descendants cleared2017: 4 descendants cleared2018: 5 descendants cleared2023: 1 descendant cleared2020: 1 descendant cleared2025: 2 descendants cleared2022: 1 descendant cleared19801990200020102020
  1. This deviceK822112 Ophthalmic KnifeSharpoint, Inc. · 1982
  2. Descendant · cites it directly · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
  3. Descendant · 2 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
  4. Descendant · 2 generations on · 12 of its ownK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · Recalled
  5. Descendant · 3 generations on · 8 of its ownK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
  6. Descendant · 3 generations on · 7 of its ownK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2010: 12012: 52013: 22014: 32015: 52016: 12017: 42018: 52020: 12022: 12023: 12025: 2
2010high 5 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 31 · See all
  • K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · cites it directly30descendants
  • K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 2 generations on19descendants
  • K120732Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · 2 generations on12descendants
  • K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · 3 generations on8descendants
  • K120426Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K822112Ophthalmic KnifeSharpoint, Inc.1982—
+1K101626Lensx Laser SystemLensx Lasers, Inc.2010—
+2K113151Ifs Laser SystemAbbott Medical Optics, Inc.2012—
+2K120732Lenssx Laser SystemAlcon Lensx, Inc.20121
+3K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc.2014—
+3K120426Victus Laser PlatformTechnolas Perfect Vision GmbH2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201250
201320
201430
201550
201610
201740
201850
202010
202210
202310
202520
FIG. 1 — Lineage of K822112, 1982–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HNN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (31)

See all 31

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101626Lensx Laser SystemLensx Lasers, Inc.201030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 3, 2004Not classifiedZ-0947-04OtherIncorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
Mar 3, 2004Not classifiedZ-0948-04OtherIncorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
Mar 3, 2004Not classifiedZ-0949-04OtherIncorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
Mar 3, 2004Not classifiedZ-0946-04OtherIncorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
Mar 3, 2004Not classifiedZ-0950-04OtherIncorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
Mar 3, 2004Not classifiedZ-0945-04OtherIncorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
Aug 21, 2003Not classifiedZ-0026-04Othertext on product handle is incorrect
May 7, 2003Not classifiedZ-0918-03OtherIncorrect handle was used in the manufacture of product 52-2761
Jan 7, 2003Not classifiedZ-0705-03Othersize mislabeled on product handle

The 5 latest of 9 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K101626 (Lensx Lasers, Inc., 2010) has gone furthest, with 30 descendants of its own.

How does its category compare?

All HNN devices

HNN Knife, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HNN

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HNN

Too few HNN 510(k)s in any year since 2007 to give a median.

Recalls per year · HNN

1in 2025

2007: 362010: 12017: 442021: 12022: 12023: 22025: 12026 (partial year): 1
2007high 44 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HNN

690in 2025

2007: 212008: 102009: 132010: 1492011: 2232012: 1122013: 1732014: 1692015: 4012016: 4352017: 4722018: 4202019: 2912020: 4932021: 4032022: 3272023: 3552024: 1,8442025: 690
2007high 1,844 (2024) · low 10 (2008)2025

MAUDE reports naming product code HNN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—3621
20080—010
20090—013
20100—1149
20111—0223
20120—0112
20130—0173
20140—0169
20150—0401
20160—0435
20170—44472
20180—0420
20190—0291
20200—0493
20210—1403
20220—1327
20230—2355
20240—01,844
20250—1690
20260—1—

More from Sharpoint, Inc.

16 FDA decisions under this applicant name. See the company

Recent decisions in HNN

The HNN category page

  • K110166Clearcut S Safety KnifeAlcon Research, Ltd. · 20114 recalls
  • K922378Ophthalmic KnifeMicroptics Development Laboratory · 1992
  • K882402Retractive Incision Micrometer (Rim) GuageOptical Center · 1988
  • K881669MVR/Stiletto Blade 20GA. - P/N 1900Advanced Surgical Products, Inc. · 1988
  • K874979Prisma Disposable MVR/Stiletto BladeAdvanced Surgical Products, Inc. · 1988

https://510kreport.com/device/K822112 · printed Nov 4, 2026

Cite this page

510(k) Report. “K822112: Ophthalmic Knife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K822112

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026