Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2920](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2920) → FLK — Thermometer, Clinical Mercury # FLK · Thermometer, Clinical Mercury _General Hospital · 21 CFR 880.2920 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK ## Overview - **Product Code:** FLK - **Device Name:** Thermometer, Clinical Mercury - **Regulation:** [21 CFR 880.2920](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2920) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. ## Recent Cleared Devices (20 of 33) Showing 20 most recent of 33 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K960185](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K960185.md) | AMSINO CLINICAL THERMOMETER | Amsia Intl., Inc. | Mar 28, 1996 | SESE | | [K960224](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K960224.md) | GERATHERM MERCUIRY FREE CLINICAL THERMOMETER | Rg Ent., Inc. | Mar 25, 1996 | SESE | | [K953465](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K953465.md) | KENTEMP | Kentron Health Care, Inc. | Dec 15, 1995 | SESE | | [K942483](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K942483.md) | CLINICAL GLASS THERMOMETER | Makol Medical Instruments Corp. | Mar 28, 1995 | SESE | | [K941673](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K941673.md) | MEDIAID UNIVERSAL THERMOMETER | Polymedica Industries, Inc. | Aug 25, 1994 | SESE | | [K940394](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K940394.md) | AMG MED BRAND CLINICAL GLASS THERMOMETER | Technolab Industries (Canada) , Ltd. | May 4, 1994 | SESE | | [K940380](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K940380.md) | AMG MED BRAND CLINICAL GLASS THERMOMETER | Amg Medical, Inc. | May 4, 1994 | SESE | | [K932991](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K932991.md) | GUARDIAN AND ANDINO MODELS | Coltemp, Inc. | Jan 28, 1994 | SESE | | [K923225](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K923225.md) | LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME | Lorrex Health Products | Jun 8, 1993 | SESE | | [K913793](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K913793.md) | SIMPEX INC. ORAL AND RECTAL THERMOMETERS | Simpex, Inc. | Dec 30, 1991 | SESE | | [K911269](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K911269.md) | MERCURY AND GLASS FEVER THERMOMETER | Steridyne Corp. | May 15, 1991 | SESE | | [K902625](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K902625.md) | CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT | Liaoning-Usa Corp. | Oct 26, 1990 | SESE | | [K903500](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K903500.md) | MASCOT THERMOTER | Mascot, Inc. | Oct 9, 1990 | SESE | | [K901790](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K901790.md) | THERMOMETER, MERCURY/CLINICAL | Perlink USA, Inc. | Jul 11, 1990 | SESE | | [K900646](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K900646.md) | MERCURY THERMOMETERS (ORAL AND RECTAL) | Abel Industries, Inc. | Jul 11, 1990 | SESE | | [K897054](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K897054.md) | CLINICAL MERCURY THERMOMETER | Cypress Medical Products, Ltd. | Mar 22, 1990 | SESE | | [K893602](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K893602.md) | GLASS MERCURY FILLED THERMOMETERS | Smith & Nephew United, Inc. | Aug 8, 1989 | SESE | | [K883573](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K883573.md) | THERMOMETER, MERCURY/CLINICAL | Umax Corp. | Nov 7, 1988 | SESE | | [K870285](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K870285.md) | THERMOMETER SHEATHES, STERILE (GLASS) | The Medical Group, Inc. | Feb 12, 1987 | SESE | | [K852301](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K852301.md) | INOX THERMOMETER JAR | Broadwest Corp. | Jul 1, 1985 | SESE | ## Top Applicants - Abco Dealers, Inc. — 3 clearances - Abel Industries, Inc. — 1 clearance - Airlife, Inc. — 1 clearance - Amg Medical, Inc. — 1 clearance - Amsia Intl., Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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