510(k) Report

510(k) · Cleared

Cleared

Suction Catheter Straight/Coude

K896730510(k) TraditionalCleared Mar 30, 1990120-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

Unoplast A/S · BSY Catheters, Suction, Tracheobronchial

Cleared on Mar 30, 1990 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 30, 1990
Review
120 days
Class
Class I
Product code
BSY
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K896730Source: FDA 510(k) database · 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
Get a 510(k) Report

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?

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 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 Unoplast A/S

7 FDA decisions under this applicant name. See the company

  • K896734Feeding TubeUnoplast A/S · 19901 recall
  • K896729Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 199014 recalls
  • K896732Unometer 500Unoplast A/S · 1990
  • K896731Oxygen CathetersUnoplast A/S · 1990
  • K896733VacconUnoplast A/S · 1990

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/K896730 · printed Nov 4, 2026

Cite this page

510(k) Report. “K896730: Suction Catheter Straight/Coude.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896730

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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