510(k) Report

510(k) · Cleared

Cleared

Respitrace Plus

K894973510(k) TraditionalCleared Oct 30, 198984-day reviewClass II21 CFR 868.2377

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

Hogan & Hartson · FLS Monitor, Apnea, Facility Use

Cleared on Oct 30, 1989 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 30, 1989
Review
84 days
Class
Class II
Product code
FLS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K894973Source: 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 FLS? 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 FLS devices

FLS Monitor, Apnea, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLS

FDA has decided no FLS device since 2007.

Median 510(k) review, days · FLS

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

Recalls per year · FLS

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FLS

1in 2019

2007: 52008: 32009: 62010: 142011: 212012: 132013: 152014: 102015: 122016: 32018: 42019: 1
2007high 21 (2011) · low 0 (2017)2025

MAUDE reports naming product code FLS, 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—15
20080—03
20090—16
20100—014
20110—021
20120—013
20130—015
20140—010
20150—012
20160—03
20170—00
20180—04
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Hogan & Hartson

26 FDA decisions under this applicant name. See the company

  • K974168Coopersurgical Infrared CoagulatorHogan & Hartson · 1998
  • K973849Bioabsorbable Bankart TackHogan & Hartson · 1998
  • K973162Dual Radiation Targeting System DRTS DrapeHogan & Hartson · 1997
  • K950169Ribosomal P Eia Test SystemHogan & Hartson · 1996
  • K942389Trocars, Trocar Sleeves and Reduction SleevesHogan & Hartson · 1996

Recent decisions in FLS

The FLS category page

  • K011597Smartmonitor 2, Model 4000Respironics Georgia, Inc. · 20022 recalls
  • K991087Hannah Wireless Vital Signs MonitorIlife Systems, Inc. · 2000
  • K962865Rembrandt SystemAirsep Corp. · 1996
  • K951246Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsProtocol Systems, Inc. · 1996
  • K832999Respiration MonitorLitton Medical Electronics · 1984

https://510kreport.com/device/K894973 · printed Nov 5, 2026

Cite this page

510(k) Report. “K894973: Respitrace Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894973

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