510(k) Report

510(k) · Cleared

Cleared

Suction Tips

K832520510(k) TraditionalCleared Oct 20, 198373-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

Wells Johnson Co. · GEA Cannula, Surgical, General & Plastic Surgery

Cleared on Oct 20, 1983 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided
Oct 20, 1983
Review
73 days
Class
Class I
Product code
GEA
Recalls
None
Predicates
0

10 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2000: 1 descendant cleared1997: 2 descendants cleared2004: 1 descendant cleared2003: 1 descendant cleared2001: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared19801990200020102020
  1. This deviceK832520 Suction TipsWells Johnson Co. · 1983
  2. Descendant · cites it directly · 4 of its ownK973268 Microaire Power Aspiration Device Pad SystemMicroaire Surgical Instruments, Inc. · 1997 · Recalled
  3. Descendant · cites it directly · 3 of its ownK984363 XPS Tissue Aspiration System, XPS Straightshot or Model 2000…Xomed, Inc. · 1999
  4. Descendant · 2 generations on · 2 of its ownK040239 Supraflow ConsoleNeomedix Corp. · 2004 · Recalled
  5. Descendant · cites it directly · 2 of its ownK992855 XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptXomed, Inc. · 2000
  6. Descendant · 3 generations on · 1 of its ownK080845 Orwell Fluid Collection and Disposal SystemCardinalhealth · 2008

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1997: 21999: 22000: 12001: 12003: 12004: 12008: 12009: 1
1997high 2 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 10 · See all
  • K973268Microaire Power Aspiration Device Pad SystemMicroaire Surgical Instruments, Inc. · 1997 · cites it directly4descendants
  • K984363XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider SystemXomed, Inc. · 1999 · cites it directly3descendants
  • K040239Supraflow ConsoleNeomedix Corp. · 2004 · 2 generations on2descendants
  • K992855XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptXomed, Inc. · 2000 · cites it directly2descendants
  • K080845Orwell Fluid Collection and Disposal SystemCardinalhealth · 2008 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K832520Suction TipsWells Johnson Co.1983—
+1K973268Microaire Power Aspiration Device Pad SystemMicroaire Surgical Instruments, Inc.19971
+1K984363XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider…Xomed, Inc.1999—
+2K040239Supraflow ConsoleNeomedix Corp.20041
+1K992855XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptXomed, Inc.2000—
+3K080845Orwell Fluid Collection and Disposal SystemCardinalhealth2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199920
200010
200110
200310
200410
200810
200910
FIG. 1 — Lineage of K832520, 1983–2009Source: 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 GEA? 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? (10)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973268Microaire Power Aspiration Device Pad SystemMicroaire Surgical Instruments, Inc.19974
K984363XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider SystemXomed, Inc.19993
K992855XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptXomed, Inc.20002
K992282Micro-France Liposuction CannulasXomed, Inc.19990
K972958Lysonix TTD Delta Scavenger Suction/Aspiration Cannulas Lysonix Infusion Diamond CannulasLysonix, Inc.19970

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, K973268 (Microaire Surgical Instruments, Inc., 1997) has gone furthest, with 4 descendants of its own.

How does its category compare?

All GEA devices

GEA Cannula, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEA

FDA has decided no GEA device since 2007.

Median 510(k) review, days · GEA

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

Recalls per year · GEA

1in 2024

2008: 12024: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · GEA

71in 2025

2007: 72008: 152009: 142010: 142011: 112012: 32013: 72014: 82015: 112016: 632017: 462018: 582019: 622020: 1582021: 1492022: 832023: 742024: 982025: 71
2007high 158 (2020) · low 3 (2012)2025

MAUDE reports naming product code GEA, 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—07
20080—115
20090—014
20100—014
20110—011
20120—03
20130—07
20140—08
20150—011
20160—063
20170—046
20180—058
20190—062
20200—0158
20210—0149
20220—083
20230—074
20240—198
20250—071
20260—0—
Cite this page

510(k) Report. “K832520: Suction Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832520

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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