510(k) Report

510(k) · Cleared

Cleared

Bobes Lens Set

K945443510(k) TraditionalCleared Jul 19, 1995254-day reviewClass I21 CFR 886.1405

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

Bobes S.A. · HPC Set, Lens, Trial, Ophthalmic

Cleared on Jul 19, 1995 after a 254-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 19, 1995
Review
254 days
Class
Class I
Product code
HPC
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K945443Source: FDA 510(k) database · 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.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All HPC devices

HPC Set, Lens, Trial, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPC

FDA has decided no HPC device since 2007.

Median 510(k) review, days · HPC

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

Recalls per year · HPC

No recall names HPC since 2007.

Adverse event reports per year · HPC

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code HPC, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

More from Bobes S.A.

3 FDA decisions under this applicant name. See the company

  • K945445Bobes Slit LampBobes S.A. · 1995
  • K945446Bobes TonometerBobes S.A. · 1995

Recent decisions in HPC

The HPC category page

  • K951437Oti Model TLS-60Oti Medical, LLC · 1995
  • K930195Ophthalmic Trial LensesOptimark Accessories and Instruments · 1994
  • K934859Contact LensesArno Intl., Inc. · 1993
  • K930446Marco Trial SetsMarco Ophthalmic, Inc. · 1993
  • K924786Burton Trial Lens SetR.H. Burton Co. · 1993

https://510kreport.com/device/K945443 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945443: Bobes Lens Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945443

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