510(k) Report

510(k) · Cleared

Cleared

Kam Sucker

K822065510(k) TraditionalCleared Aug 16, 198233-day reviewClass I21 CFR 878.4800

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

The Anspach Effort, Inc. · KDC Instrument, Surgical, Disposable

Cleared on Aug 16, 1982 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 16, 1982
Review
33 days
Class
Class I
Product code
KDC
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared19801990200020102020
  1. This deviceK822065 Kam SuckerThe Anspach Effort, Inc. · 1982
  2. Descendant · cites it directly · 1 of its ownK971036 Odontit Autogenous Bone Collection DeviceInterpore Intl. · 1997
  3. Descendant · 2 generations on · 0 of its ownK973248 Imtec Bone Collector SystemImtec Corp. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K971036Odontit Autogenous Bone Collection DeviceInterpore Intl. · 1997 · cites it directly1descendant
  • K973248Imtec Bone Collector SystemImtec Corp. · 1997 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K822065Kam SuckerThe Anspach Effort, Inc.1982—
+1K971036Odontit Autogenous Bone Collection DeviceInterpore Intl.1997—
+2K973248Imtec Bone Collector SystemImtec Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
FIG. 1 — Lineage of K822065, 1982–1997Source: 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.

Planning a device in KDC? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K971036Odontit Autogenous Bone Collection DeviceInterpore Intl.19971

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, K971036 (Interpore Intl., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KDC devices

KDC Instrument, Surgical, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDC

FDA has decided no KDC device since 2007.

Median 510(k) review, days · KDC

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

Recalls per year · KDC

1in 2022

2007: 22010: 22011: 42022: 1
2007high 4 (2011) · low 0 (2008)2026

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

Adverse event reports per year · KDC

7in 2025

2007: 22008: 72010: 92011: 62012: 122013: 5382014: 172015: 152016: 112017: 92018: 712019: 162020: 132021: 112022: 102023: 152024: 142025: 7
2007high 538 (2013) · low 0 (2009)2025

MAUDE reports naming product code KDC, 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—22
20080—07
20090—00
20100—29
20110—46
20120—012
20130—0538
20140—017
20150—015
20160—011
20170—09
20180—071
20190—016
20200—013
20210—011
20220—110
20230—015
20240—014
20250—07
20260—0—

More from The Anspach Effort, Inc.

60 FDA decisions under this applicant name. See the company

  • K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc. · 2022
  • K183545Anspach Helix Dissection ToolsThe Anspach Effort, Inc. · 2019
  • K180063OCM-G1 AttachmentThe Anspach Effort, Inc. · 2018
  • K133604Anspach EG1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc. · 201411 recalls
  • K131053Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemThe Anspach Effort, Inc. · 20133 recalls

Recent decisions in KDC

The KDC category page

  • K943229Disposable Surgical Scissors and ForcepsY.M.K. International Co., Ltd. · 1994
  • K936226Surgimed Breast Localization Needle Wire SetMeadox Medicals, Div. Boston Scientific Corp. · 1994
  • K920153Thermuff BagTechstyles · 1992
  • K920263Manual Surgical InstrumentsPhoenix Instruments Div. · 1992
  • K915064Disposable Cautery Abrasive PadAmerican Medical Mfg., Inc. · 1992

https://510kreport.com/device/K822065 · printed Nov 5, 2026

Cite this page

510(k) Report. “K822065: Kam Sucker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K822065

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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