510(k) Report

510(k) · Cleared

Cleared

Scanlan Vascu-Statt II

K841515510(k) TraditionalCleared Jun 5, 198454-day reviewClass I21 CFR 886.4070

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

Scanlan Intl., Inc. · HRG Engine, Trephine, Accessories, Ac-Powered

Cleared on Jun 5, 1984 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 5, 1984
Review
54 days
Class
Class I
Product code
HRG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K841515Source: 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 HRG? 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 HRG devices

HRG Engine, Trephine, Accessories, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRG

FDA has decided no HRG device since 2007.

Median 510(k) review, days · HRG

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

Recalls per year · HRG

No recall names HRG since 2007.

Adverse event reports per year · HRG

1in 2025

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

MAUDE reports naming product code HRG, 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—00
20240—00
20250—01
20260—0—

More from Scanlan Intl., Inc.

19 FDA decisions under this applicant name. See the company

  • K960372Scanlan Heifetz Aneurysm Elgiloy Clip SystemScanlan Intl., Inc. · 1996
  • K945474Scanlan (R) Thoracoscopic Scissors, Clamp, Forceps, Needle HolderScanlan Intl., Inc. · 1994
  • K911184Scanlan/Taheri ValvulotomeScanlan Intl., Inc. · 1992
  • K864919Scanlan (TM) Vein/Graft HolderScanlan Intl., Inc. · 1987
  • K864920Scanlan (TM) Instrument TrayScanlan Intl., Inc. · 1987

Recent decisions in HRG

The HRG category page

  • K013151Asmotom Automated Trephine SystemBkg Opthalmics USA, Inc. · 2001
  • K981063Automated Corneal TrephineLaser Center Dev. Corp. · 1998
  • K843957Ultrathin/SP LensOptical Systems Intl., Inc. · 1985
  • K823901Trephine Blades-Various ModelsEdward Weck, Inc. · 1983
  • K791763(Micro-Keratron, Micro Duct Trephine)Intl. Ophthalmic Industries Corp. · 1979

https://510kreport.com/device/K841515 · printed Nov 6, 2026

Cite this page

510(k) Report. “K841515: Scanlan Vascu-Statt II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841515

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