Cleared Traditional

K971235 - ALEXANDER MANUFACTURING CO. RECHARGEABL...

K971235 is an FDA 510(k) clearance for ALEXANDER MANUFACTURING CO. RECHARGEABL..., manufactured by Alexander Mfg. Co.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K971235 · Alexander Mfg. Co. · Anesthesiology device
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Jun 1997
Decision
64d
Days
Class 2
Risk

K971235 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on June 5, 1997 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alexander Mfg. Co. devices

FDA 510(k) Submission Details - K971235

510(k) Number K971235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1997
Decision Date June 05, 1997
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 140d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 476
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K971235.
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764
K971827 · Alexander Mfg. Co. · Aug 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
K971828 · Alexander Mfg. Co. · Aug 1997
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
K970763 · Medical Data Electronics · Jul 1997
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997
8500A PULSE OXIMETER
K945290 · Nonin Medical, Inc. · Feb 1997