510(k) Report

510(k) · Cleared

Cleared

Orthopaedic and Spinal Ring Currettes

K882072510(k) TraditionalCleared Jun 17, 198831-day reviewClass II21 CFR 882.5030

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

Karlin Technology, Inc. · JXH Methyl Methacrylate For Aneurysmorrhaphy

Cleared on Jun 17, 1988 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 17, 1988
Review
31 days
Class
Class II
Product code
JXH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K882072Source: 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 JXH? 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
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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 JXH devices

JXH Methyl Methacrylate For Aneurysmorrhaphy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JXH

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXH

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

Recalls per year · JXH

No recall names JXH since 2007.

Adverse event reports per year · JXH

2in 2022

2021: 12022: 2
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code JXH, 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
20071—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—01
20220—02
20230—00
20240—00
20250—00
20260—0—

More from Karlin Technology, Inc.

17 FDA decisions under this applicant name. See the company

  • K903969Suction Retractor (Tower Attach.)for Crank Fram RetKarlin Technology, Inc. · 1990
  • K893203Bone ScrewKarlin Technology, Inc. · 1990
  • K893201Bone PlateKarlin Technology, Inc. · 1990
  • K882525Spinal MicroknifeKarlin Technology, Inc. · 1988
  • K882519X-Ray MarkerKarlin Technology, Inc. · 1988

Recent decisions in JXH

The JXH category page

  • K071776Aneuroplastic, Model 43-1290Codman & Shurtleff, Inc. · 2007
  • K873688Aneuroplastic, Acrylic Aneuryomorrhaply MaterialDentsply Intl. · 1987

https://510kreport.com/device/K882072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K882072: Orthopaedic and Spinal Ring Currettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K882072

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