510(k) Report

510(k) · Cleared

Cleared

Intermed, Ins Sterile Water/Saline

K842166510(k) TraditionalCleared Feb 12, 1985257-day reviewClass I21 CFR 868.6810

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

Intermed, Inc. · BSY Catheters, Suction, Tracheobronchial

Cleared on Feb 12, 1985 after a 257-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
Feb 12, 1985
Review
257 days
Class
Class I
Product code
BSY
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK842166 Intermed, Ins Sterile Water/SalineIntermed, Inc. · 1985
  2. Descendant · cites it directly · 0 of its ownK973734 Sterile Water for Device Irrigation/ Sterile Saline for Device…Welcon, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K973734Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationWelcon, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K842166Intermed, Ins Sterile Water/SalineIntermed, Inc.1985—
+1K973734Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationWelcon, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K842166, 1985–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 BSY? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K973734Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationWelcon, 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, K973734 (Welcon, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BSY devices

BSY Catheters, Suction, Tracheobronchial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSY

FDA has decided no BSY device since 2007.

Median 510(k) review, days · BSY

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

Recalls per year · BSY

1in 2023

2014: 1, 1 Class I2017: 112019: 12020: 12021: 32023: 1
2007high 11 (2017) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSY

163in 2025

2007: 312008: 172009: 372010: 202011: 422012: 542013: 482014: 652015: 2952016: 3152017: 1132018: 7212019: 1212020: 1492021: 632022: 3092023: 1982024: 2102025: 163
2007high 721 (2018) · low 17 (2008)2025

MAUDE reports naming product code BSY, 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—031
20080—017
20090—037
20100—020
20110—042
20120—054
20130—048
20140—1 (1)65
20150—0295
20160—0315
20170—11113
20180—0721
20190—1121
20200—1149
20210—363
20220—0309
20230—1198
20240—0210
20250—0163
20260—0—

More from Intermed, Inc.

16 FDA decisions under this applicant name. See the company

  • K900857Non Sterile Parenteral Supply KitIntermed, Inc. · 1990
  • K833126Dressing Change TraysIntermed, Inc. · 1984
  • K833573Central Vein Cath. Tray CC-20-1420Intermed, Inc. · 1984
  • K833574Percutaneous Sheath Introducer TraysIntermed, Inc. · 1984
  • K833139Acute Hemodialysis TraysIntermed, Inc. · 1983

Recent decisions in BSY

The BSY category page

  • K031997Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction SystemMallinckrodt Dar S.R.L. · 2003
  • K992902Ambu Hand Power Suction PumpAmbu, Inc. · 1999
  • K982945Dual Purpose Closed CatheterSpirit Medical Systems, Inc. · 1998
  • K981910Suction CatheterNi-Med, Inc. · 1998
  • K972258HI-Care Closed Suction SystemMallinckrodt Medical · 1997

https://510kreport.com/device/K842166 · printed Nov 4, 2026

Cite this page

510(k) Report. “K842166: Intermed, Ins Sterile Water/Saline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K842166

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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