510(k) Report

510(k) · Cleared

Cleared

Mai Hydroseal Implant for Scleral Buck

K831773510(k) TraditionalCleared Aug 16, 198375-day reviewClass II21 CFR 886.3300

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

Bcd Products, Inc. · HQJ Implant, Absorbable, (Scleral Buckling Methods)

Cleared on Aug 16, 1983 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 16, 1983
Review
75 days
Class
Class II
Product code
HQJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K831773Source: 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.

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

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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 HQJ devices

HQJ Implant, Absorbable, (Scleral Buckling Methods): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQJ

FDA has decided no HQJ device since 2007.

Median 510(k) review, days · HQJ

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

Recalls per year · HQJ

No recall names HQJ since 2007.

Adverse event reports per year · HQJ

5in 2016

2007: 12016: 5
2007high 5 (2016) · low 0 (2008)2025

MAUDE reports naming product code HQJ, 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—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—05
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Bcd Products, Inc.

2 FDA decisions under this applicant name. See the company

  • K813547ThermascanBcd Products, Inc. · 1982

Recent decisions in HQJ

The HQJ category page

  • K896350Titan Air Spectacle FrameAcces Intl. Eyewear · 1989
  • K884362Labeling Changes to Fyodorov Collagen Corneal SHLDBausch & Lomb Pharmaceutical, Inc. · 1988
  • K875014Labtician Retinal ImplantsLabtician Products, Inc. · 1988
  • K760550Implant, Silicone and TantalumMedical Instrument Research Assoc., Inc. · 1976

https://510kreport.com/device/K831773 · printed Nov 3, 2026

Cite this page

510(k) Report. “K831773: Mai Hydroseal Implant for Scleral Buck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K831773

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