510(k) Report

510(k) · Cleared

Cleared

Hypodermic Needle Sheath Holder

K882405510(k) TraditionalCleared Jun 29, 198819-day reviewClass II21 CFR 880.2500

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

Ansr Ent., Inc. · FMJ Manometer, Spinal-Fluid

Cleared on Jun 29, 1988 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 29, 1988
Review
19 days
Class
Class II
Product code
FMJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K882405Source: 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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  • 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 FMJ devices

FMJ Manometer, Spinal-Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMJ

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMJ

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

Recalls per year · FMJ

No recall names FMJ since 2007.

Adverse event reports per year · FMJ

1in 2025

2007: 12009: 12010: 72011: 12012: 282013: 1012014: 1762015: 842019: 12023: 12025: 1
2007high 176 (2014) · low 0 (2008)2025

MAUDE reports naming product code FMJ, 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—01
20100—07
20110—01
20120—028
20130—0101
20140—0176
20150—084
20160—00
20171—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—01
20240—00
20250—01
20260—0—

Recent decisions in FMJ

The FMJ category page

  • K170305Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH Medizintechnologie · 2017
  • K032432Busse Hospital Disposables Spinal ManometerBusse Hospital Disposables, Inc. · 20037 recalls
  • K970287Lumbar Puncture KitB.Braun Medical, Inc. · 1997
  • K963570Sims Adult Lumbar Puncture Kit (4800-20,4801-20,4806-22,4807-22)Smiths Industries Medical Systems, Inc. · 1996
  • K910089Mega Lumbar Puncture KitMegadyne Medical Products, Inc. · 1991

https://510kreport.com/device/K882405 · printed Nov 5, 2026

Cite this page

510(k) Report. “K882405: Hypodermic Needle Sheath Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K882405

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