510(k) Report

510(k) · Decided

Decided

Manan Ubk Ultrasonic Guided Biopsy Kit

K852105510(k) TraditionalDecided Jun 18, 198534-day reviewClass I21 CFR 876.4730

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

Manan Manufacturing Co., Inc. · FCH Tray, Biopsy, Without Biopsy Instruments

Cleared on Jun 18, 1985 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 18, 1985
Review
34 days
Class
Class I
Product code
FCH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K852105Source: 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 FCH? 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 FCH devices

FCH Tray, Biopsy, Without Biopsy Instruments: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FCH

FDA has decided no FCH device since 2007.

Median 510(k) review, days · FCH

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

Recalls per year · FCH

1in 2025

2012: 22016: 12023: 12025: 1
2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · FCH

2in 2018

2013: 12017: 12018: 2
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code FCH, 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—20
20130—01
20140—00
20150—00
20160—10
20170—01
20180—02
20190—00
20200—00
20210—00
20220—00
20230—10
20240—00
20250—10
20260—0—

More from Manan Manufacturing Co., Inc.

20 FDA decisions under this applicant name. See the company

  • K873208Manan Turner Style NeedleManan Manufacturing Co., Inc. · 1987
  • K864405Manan Contrast Media Administration SetManan Manufacturing Co., Inc. · 1986
  • K863848Manan Brest Tumor Localization NeedleManan Manufacturing Co., Inc. · 1986
  • K851833Manan Seldinger NeedleManan Manufacturing Co., Inc. · 1985
  • K852501Myelogram Procedure TrayManan Manufacturing Co., Inc. · 1985

Recent decisions in FCH

The FCH category page

  • K882673Sigma 1 Wobbler Biopsy KitKontron Instruments, Inc. · 1988

https://510kreport.com/device/K852105 · printed Nov 6, 2026

Cite this page

510(k) Report. “K852105: Manan Ubk Ultrasonic Guided Biopsy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K852105

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