510(k) Report

510(k) · Cleared

Cleared

Magnet Pad

K896802510(k) TraditionalCleared Dec 27, 198926-day reviewClass I21 CFR 862.2050

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

Westmark, Sterile Packing Systems, Inc. (Sps) · LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Cleared on Dec 27, 1989 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 27, 1989
Review
26 days
Class
Class I
Product code
LXG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K896802Source: 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 LXG devices

LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXG

FDA has decided no LXG device since 2007.

Median 510(k) review, days · LXG

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

Recalls per year · LXG

2in 2019

2007: 12009: 22011: 22012: 12018: 92019: 2
2007high 9 (2018) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LXG

1,253in 2025

2007: 72008: 12009: 12010: 32011: 42012: 82013: 212014: 72015: 152016: 122017: 142018: 252019: 272020: 152021: 112022: 132023: 112024: 112025: 1,253
2007high 1,253 (2025) · low 1 (2008)2025

MAUDE reports naming product code LXG, 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—17
20080—01
20090—21
20100—03
20110—24
20120—18
20130—021
20140—07
20150—015
20160—012
20170—014
20180—925
20190—227
20200—015
20210—011
20220—013
20230—011
20240—011
20250—01,253
20260—0—
Cite this page

510(k) Report. “K896802: Magnet Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K896802

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