510(k) Report

FDA applicant

Turtle Shell Technologies Private Limited

Bengaluru, IN1 decision2022–20220 recalls

FDA records 1 decision for Turtle Shell Technologies Private Limited (Bengaluru, IN) in 2022: 1 510(k) clearance. All are in product code BZQ (Monitor, Breathing Frequency). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Turtle Shell Technologies Private Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Turtle Shell Technologies Private Limited by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Turtle”

FDA records each applicant name separately; these may or may not be the same firm.