510(k) Report

510(k) · Cleared

Cleared

Naman Potts Cournand Needle

K851832510(k) TraditionalCleared Jul 11, 198576-day reviewClass I21 CFR 870.4500

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. · DWS Instruments, Surgical, Cardiovascular

Cleared on Jul 11, 1985 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 11, 1985
Review
76 days
Class
Class I
Product code
DWS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK851832 Naman Potts Cournand NeedleManan Manufacturing Co., Inc. · 1985
  2. Descendant · cites it directly · 0 of its ownK974742 Manan Potts-Cournand NeedleMedical Device Technologies, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K974742Manan Potts-Cournand NeedleMedical Device Technologies, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K851832Naman Potts Cournand NeedleManan Manufacturing Co., Inc.1985—
+1K974742Manan Potts-Cournand NeedleMedical Device Technologies, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K851832, 1985–1998Source: FDA 510(k) summaries, read by 510(k) Report · 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974742Manan Potts-Cournand NeedleMedical Device Technologies, Inc.19980

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.

What does this lineage say?

  • Of its descendants, K974742 (Medical Device Technologies, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DWS devices

DWS Instruments, Surgical, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWS

FDA has decided no DWS device since 2007.

Median 510(k) review, days · DWS

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

Recalls per year · DWS

1in 2022

2010: 12011: 12016: 12022: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DWS

12in 2025

2007: 202008: 152009: 442010: 272011: 552012: 332013: 342014: 432015: 262016: 332017: 402018: 602019: 282020: 282021: 322022: 352023: 182024: 482025: 12
2007high 60 (2018) · low 12 (2025)2025

MAUDE reports naming product code DWS, 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—020
20080—015
20090—044
20100—127
20110—155
20120—033
20130—034
20140—043
20150—026
20160—133
20170—040
20180—060
20190—028
20200—028
20210—032
20220—135
20230—018
20240—048
20250—012
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 DWS

The DWS category page

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  • K964445Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)Dlp, Inc. · 1997
  • K962771Burke Congenital Thoracoscopy InstrumentsPilling Weck, Inc. · 1996
  • K955689RNS Sterile, Disposable Digital Angiographic TrayContour Fabricators of Florida, Inc. · 1996
  • K960139G.E. Sterile Angiographic TrayGE Medical Systems · 1996

https://510kreport.com/device/K851832 · printed Nov 4, 2026

Cite this page

510(k) Report. “K851832: Naman Potts Cournand Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K851832

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