Cleared Traditional

K070100 - HASELMEIER PEN

K070100 is an FDA 510(k) clearance for HASELMEIER PEN, manufactured by Haselmeier Sarl. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K070100 · Haselmeier Sarl · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
70d
Days
Class 2
Risk

K070100 is an FDA 510(k) clearance for the HASELMEIER PEN. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Haselmeier Sarl (Severna Park, US). The FDA issued a Cleared decision on March 21, 2007 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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.

FDA 510(k) Submission Details - K070100

510(k) Number K070100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2007
Decision Date March 21, 2007
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 752
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K070100.
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
K070264 · Terumo Europe N.V. · May 2007
EVICEL APPLICATION DEVICE
K070575 · Omrix Biopharmaceuticals , Ltd. · May 2007
TEXIUM SYRINGE
K071108 · Cardinal Health, Alaris Products · May 2007
TOP FINE INSULIN SYRINGE
K063348 · Daejin Tech Medical Manufacturing Co., Ltd. · Mar 2007
CAPTION APPLICATOR
K063535 · Smith & Nephew, Inc. · Feb 2007
FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC
K062753 · Surgimed, Inc. · Feb 2007
K070100 · HASELMEIER PEN
Download PDF FDA Summary Haselmeier Sarl