510(k) Report

510(k) · Cleared

Cleared

Maxi-Flow Suction Handle/the Reel Thing Tubing Reel

K955149510(k) TraditionalCleared Jan 24, 199672-day reviewClass II21 CFR 880.6740

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

Bio-Medical Devices, Inc. · BYY Tube, Aspirating, Flexible, Connecting

Cleared on Jan 24, 1996 after a 72-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 24, 1996
Review
72 days
Class
Class II
Product code
BYY
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K955149Source: 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 BYY? 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 lists a 510(k) statement for it but has not posted the file, 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 BYY devices

BYY Tube, Aspirating, Flexible, Connecting: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYY

FDA has decided no BYY device since 2007.

Median 510(k) review, days · BYY

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

Recalls per year · BYY

1in 2008

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

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

Adverse event reports per year · BYY

14in 2025

2009: 42010: 22011: 12013: 52014: 32015: 22016: 202017: 342018: 122019: 182020: 232021: 112022: 112023: 112024: 32025: 14
2007high 34 (2017) · low 0 (2007)2025

MAUDE reports naming product code BYY, 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—10
20090—04
20100—02
20110—01
20120—00
20130—05
20140—03
20150—02
20160—020
20170—034
20180—012
20190—018
20200—023
20210—011
20220—011
20230—011
20240—03
20250—014
20260—0—

More from Bio-Medical Devices, Inc.

7 FDA decisions under this applicant name. See the company

  • K040485Maxair Surgical Helmet SystemBio-Medical Devices, Inc. · 20041 recall
  • K981888Smoke-EvacBio-Medical Devices, Inc. · 1998
  • K955151Maxi-Flow Suction Tube/Top Gun Suction IrrigatorBio-Medical Devices, Inc. · 1996
  • K955150Maxi-FlowBio-Medical Devices, Inc. · 1996
  • K940156The Reel ThingBio-Medical Devices, Inc. · 1994

Recent decisions in BYY

The BYY category page

  • K960616Vitaflow Suction/Aspiration Tubing SetVital Concepts, Inc. · 19966 recalls
  • K960218Connecting TubingCustom Pack Reliability · 1996
  • K955151Maxi-Flow Suction Tube/Top Gun Suction IrrigatorBio-Medical Devices, Inc. · 1996
  • K955150Maxi-FlowBio-Medical Devices, Inc. · 1996
  • K922989Wiltek Irrigaiton/Aspiration Tube SetWiltek Medical, Inc. · 1994

https://510kreport.com/device/K955149 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955149: Maxi-Flow Suction Handle/the Reel Thing Tubing Reel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955149

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