Cleared Traditional

Dozee VS (K221555) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K221555 · Turtle Shell Technologies Private Limited · Anesthesiology device
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Dec 2022
Decision
198d
Days
Class 2
Risk

K221555 is an FDA 510(k) clearance for the Dozee VS. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Turtle Shell Technologies Private Limited (Bengaluru, IN). The FDA issued a Cleared decision on December 15, 2022 after a review of 198 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Turtle Shell Technologies Private Limited devices

Submission Details

510(k) Number K221555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2022
Decision Date December 15, 2022
Days to Decision 198 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 140d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Hammond Clinical Trial Consulting, LLC
David Hammond

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05153460 Terminated Observational Industry-sponsored

Pilot Clinical Evaluation of Dozee VS, a Contactless Continuous Vital Parameters Monitoring System in Hospital Patients

Pilot Clinical Evaluation of Dozee VS in Hospital Patients

10
Patients (actual)
1
Site
Condition studied No Specific Medical Conditions or Disease States
Eligibility All sexes · 18 Years+
Sponsor Turtle Shell Technologies Pvt. Ltd. (industry)
Started 2021-12-09 → Primary completion 2022-04-14
Primary outcome
RMSD of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate
Secondary outcome
Motion Notification Accuracy - DUI (%)
View full study on ClinicalTrials.gov

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 34
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K221555.
Airmod
K242798 · Heroic Faith International , Ltd. · Feb 2025
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K240271 · Linshom Medical, Inc. · Sep 2024
Respiree Cardio-Respiratory Monitor
K223681 · Respiree Pte, Ltd. · Mar 2023
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
K223246 · Baxter Healthcare Corproration · Nov 2022
RespiraSense
K220111 · Pmd Solutions · Oct 2022
Breathe Easy Mobile Respiratory Monitor (MRM)
K211387 · Sound Life Sciences, Inc. · Nov 2021