YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE— 510(k) K962070

Name: FDA 510(k) clearance K962070
Creator: U.S. Food and Drug Administration
Published: 1996-07-19

Substantially Equivalent

Yellow Springs Instrument Co., Inc.

FDA 510(k) clearance K962070 for YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE, Substantially Equivalent on 1996-07-19. Applicant: Yellow Springs Instrument Co., Inc.. Device class: 2.

Clearance details

Applicant: Yellow Springs Instrument Co., Inc.
Product code: Code FLL
Device class: Class 2
Regulation: 21 CFR 880.2910
Advisory panel: General Hospital
Date received: 1996-05-28
Decision date: 1996-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yellow Springs, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FLL

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More clearances from Yellow Springs Instrument Co., Inc.

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K922821 — YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES1992-11-23
K922007 — YSI MODEL 441A AIRWAY TEMPERATURE PROBE1992-11-04
K910633 — YSI MODEL 1500 BLOOD GLUCOSE ANALYZER1991-04-12
K910718 — YSI PRECISION 4000 THERMOMETER1991-04-09
K901131 — YSI MODEL 1500 SPORT L-LACTATE ANALYZER1990-08-27

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K962070

K-number listed on FDA's recall record

Z-0926-2022 — The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.Class II·Ongoing·Philips North America, LLC·20220207
Z-0395-2018 — Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designed to be used with any patient monitoring system designed to accept 400 Series temperature probes.Class II·Ongoing·Measurement Specialties Inc·20170313

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962070.

Data sourced from openFDA. This site is unofficial and independent of the FDA.