510(k) Report

510(k) · Cleared

Cleared

Optha Prep

K871706510(k) TraditionalCleared May 18, 198717-day reviewClass II21 CFR 878.4370

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

Treace Medical, Inc. · HMT Drape, Patient, Ophthalmic

Cleared on May 18, 1987 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 18, 1987
Review
17 days
Class
Class II
Product code
HMT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K871706Source: 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 has not posted a summary or statement for it, 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 HMT devices

HMT Drape, Patient, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HMT

FDA has decided no HMT device since 2007.

Median 510(k) review, days · HMT

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

Recalls per year · HMT

No recall names HMT since 2007.

Adverse event reports per year · HMT

1in 2025

2008: 32014: 22017: 22020: 32022: 12025: 1
2007high 3 (2008) · low 0 (2007)2025

MAUDE reports naming product code HMT, 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—03
20090—00
20100—00
20110—00
20120—00
20130—00
20140—02
20150—00
20160—00
20170—02
20180—00
20190—00
20200—03
20210—00
20220—01
20230—00
20240—00
20250—01
20260—0—

More from Treace Medical, Inc.

80 FDA decisions under this applicant name. See the company

  • K883727Bucket Prosthesis PorpTreace Medical, Inc. · 1989
  • K882349Mallet, SurgicalTreace Medical, Inc. · 1988
  • K874779Bipolator 50Treace Medical, Inc. · 1988
  • K873154Treace Magnum Oto-Tool SystemTreace Medical, Inc. · 1987
  • K872000Eye GardTreace Medical, Inc. · 1987

Recent decisions in HMT

The HMT category page

  • K945738Visiflex Ophthalmic Surgical Incise DrapeVisitec Co. · 1995
  • K905460Sterile Disposable Drape/Ophthalmic SurgeryAngiosystems, Inc. · 1991
  • K872620Solos Eyesite DrapesSolos Ophthalmology · 1987
  • K854613Surgical Drapes, OphthalminCharles Atkins & Co. · 1986
  • K831340Drain-R-Drape (EyeSur-Tech, Inc. · 1983

https://510kreport.com/device/K871706 · printed Nov 5, 2026

Cite this page

510(k) Report. “K871706: Optha Prep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871706

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